Mean 24-h Blood Pressure Research Articles

Initial treatment with a single capsule containing half-dose quadruple therapy vs standard-dose dual therapy in hypertensive patients (QUADUAL): a randomized, blinded, crossover trial

BackgroundGuidelines recognized dual combination in initial antihypertensive therapy. Studies found that low-dose quadruple combination were superior to monotherapy. However, whether low-dose quadruple therapy is better than dual combination is unknown.MethodsA randomized blinded crossover trial was conducted to compare the efficacy and safety of low-dose quadruple antihypertensives (irbesartan 75 mg + metoprolol 23.75 mg + amlodipine 2.5 mg + indapamide 1.25 mg) with standard-dose dual antihypertensives (irbesartan 150 mg + amlodipine 5 mg), both in a single pill, in the initial treatment of patients with mild to moderate hypertension. Patients were randomly assigned in a 1:1 ratio to two crossover sequences. Each sequence received four-weeks of either half-dose quadruple antihypertensives or standard-dose dual antihypertensives, followed by a two-week washout and crossover for four-weeks. Participants and researchers were blinded. The main outcomes were the reduction of blood pressure and safety outcomes. Analyses were per intention to treat.ResultsA total of 90 eligible participants were randomized between July 13, 2022, and April 20, 2023. The mean age was 43.88 years (SD 10.31), and 25.6% were women. The mean baseline 24-h blood pressure was 145.59/93.84 mm Hg. Compared to the standard-dose dual treatment, the half-dose quadruple treatment resulted in a further reduction in mean 24-h blood pressure by 4.72/4.17 mm Hg (P < 0.001 for both systolic and diastolic blood pressure), mean daytime blood pressure by 5.52/4.73 mm Hg (P < 0.001 for both), mean nighttime blood pressure by 2.37/2.25 mm Hg (P = 0.034 and 0.014, respectively), and mean office blood pressure by 2.91/1.73 mm Hg (P < 0.001 and 0.014, respectively). Apart from significant increases of fasting blood glucose (P = 0.029) and blood uric acid (P < 0.001) in the half-dose quadruple group, no other adverse events or changes in laboratory values differed significantly between the two treatments.ConclusionsInitiating treatment with half-dose quadruple combination therapy was more effective in lowering blood pressure than standard-dose dual therapy. The safety of half-dose quadruple therapy was comparable.Trial registrationClinicalTrials.gov Identifier: NCT05377203.

Abstract 4134668: Title: Mandibular advancement device versus CPAP on cardiovascular health and quality of life in OSA a pre-specified 12 months follow up of outcomes

Background: Obstructive sleep apnoea (OSA) is a significant cause of hypertension. ACC/AHA Guidelines recommended screening and treatment of OSA in patients with hypertension; however, evidence comparing mandibular advancement devices (MAD) to continuous positive airway pressure (CPAP) on cardiovascular health is lacking. We present the complete 12 months follow-up data on the comparative effectiveness of MAD versus CPAP in ambulatory BP reduction, QoL, cardiac arrhythmia, and myocardial remodelling. Method: In a randomized, non-inferiority trial (margin 1.5 mmHg), 321 participants, aged over 40, with hypertension and high cardiovascular risk were recruited. Of these, 220 participants with OSA (apnoea–hypopnea index ≥15 events/h) were randomized to either MAD or CPAP (1:1). Pre-specified secondary outcomes include: ambulatory BP, quality of life (QoL) (sleep-specific: ESS, SAQLI, FOSQ; non-sleep-specific: SF-36, EQ-5D), ambulatory ECG monitoring, and cardiac MRI. Results: A total of 89 (80.9% of 110) participants from MAD, and 91 (82.7% of 110) participants from CPAP completed 12 months follow-up. The median daily usage was 5.5 hours for MAD and 4.9 hours for CPAP. The between-group difference in 24h mean BP from baseline to 12 months was - 0.57 mmHg (95% confidence interval: (-2.53 to 1.39, non-inferiority P &lt; 0.001). Compared with the CPAP group, MAD group demonstrated a larger reduction in all the 24h with the most pronounced differences observed in the asleep BP parameters (Table 1). Both the MAD and CPAP improved QoL (Table 2). CPAP had greater improvement in FOSQ from sleep-specific questionnaires (P=0.038), and social QoL in SF-36 from non-sleep-specificl questionnaires (P=0.013). The ambulatory ECG monitoring (MAD: 2.8 ± 1.0 days, CPAP: 2.3 ± 1.1 days) showed no between-group differences in % atrial fibrillation(P=0.209), % ventricular ectopic isolated count (P=0.790) and % supraventricular ectopic isolated count (P= 0.333). The cardiac MRI sub-study (101 participants : MAD= 45, CPAP= 56) showed CPAP had greater improvement in right ventricular stroke volume (P=0.023) and MAD had greater improvement in circumferential strain favours the MAD group (P=0.015) (Table 3). Conclusion: At 12 months , MAD was non-inferior to CPAP for reducing 24h mean arterial BP. MAD showed greater reduction in 24h BPs, especially during asleep. While both the MAD and CPAP are effective in improving QoL, CPAP is more effective in improving FOSQ and social QoL (SF-36).

Abstract 4125636: Impaired blood pressure regulation in post-COVID-19 postural orthostatic tachycardia syndrome: novel disease mechanisms beyond sinus tachycardia

Background: Postural orthostatic tachycardia syndrome (POTS) is a prevalent cardiovascular disorder after COVID-19 infection. Although POTS is characterized by the presence of sinus tachycardia, other hemodynamic disturbances including blood pressure (BP) regulation, remain largely unexplored. Aims: We investigated BP changes using 24-hour ambulatory-BP-monitoring in patients with new-onset POTS after COVID-19 compared with pre-pandemic healthy controls. Methods: We performed a case-control study in 100 verified COVID-19 patients with new-onset POTS (mean age 40.0±12.9 years, 85% women) diagnosed by positive head-up tilt-testing versus 100 healthy controls (mean age 45.0±14.6 years, 70% women) from a population-based cohort with negative active standing test, no history of syncope, orthostatic intolerance, or endocrine disease. We analyzed 24-hour Systolic BP (SBP) and hypotensive SBP episodes (&lt;80, &lt;90, and &lt;100mmHg). Results: Study characteristics are illustrated in the Table . Post-COVID-19 POTS patients had significantly higher nighttime-SBP, but not daytime-SBP, and more daytime SBP hypotensive episodes (&lt;80, &lt;90, and &lt;100 mmHg, Figure ) compared with controls. Non-dipper (34% vs 19%, p&lt;0.001) and reverse dipper patterns (9% vs 0 %, &lt;0.001) were more frequent in post-COVID-19 POTS. In the logistic regression, post-COVID-19 POTS was associated with significantly higher mean 24h SBP (odds ratio (OR) 1.08, 95%CI 1.04-1.11, p&lt;0.001) and nighttime SBP (OR 1.07, 95%CI 1.04-1.10, p&lt;0.001), independently of age and sex. Conclusions: Post-COVID-19 POTS patients demonstrate higher mean 24h and nighttime systolic BP, and show signs of disrupted BP regulation compared with healthy controls. They also have more daytime hypotensive episodes. Future studies are needed to assess if post-COVID-19 POTS patients may benefit from tailored BP therapy.

Efficacy of Olmesartan/Amlodipine Single-Pill Combination on 24-h Mean Systolic Blood Pressure Measured by Ambulatory Monitoring in Non-Responders to Valsartan or Candesartan Monotherapy.

The aim of this study was to evaluate the efficacy of olmesartan/amlodipine (OLM/AML) single-pill combination (SPC) therapy using ambulatory blood pressure monitoring (ABPM) in non-responders to valsartan or candesartan monotherapy. Isolated systolic hypertension (ISH) is the most prevalent form of hypertension in middle-aged and elderly individuals. Patients aged over 55 years who did not achieve the target systolic blood pressure (SBP < 140mmHg) with valsartan 80mg or candesartan 8mg for at least 4 weeks were included. Doses were escalated from 20/5mg to 40/5mg and finally to 40/10mg of OLM/AML SPC until patients reached the target SBP. Efficacy was assessed via ABPM by comparing baseline values with those in the 12th week. Office blood pressure (OBP) and brachial-ankle pulse wave velocity (baPWV) were assessed at baseline, weeks 4, 8, and 12. Fifty-four patients (average age 64 ± 6 years; 33 males) participated. The 24-h mean BPs decreased significantly from an average of 146.2 ± 12.7/93.3 ± 9.2mmHg to 129.7 ± 14.3/83.4 ± 10.7mmHg (p < 0.001), and pulse pressures (PPs) from ABPM were reduced (p < 0.001). Additionally, significant reductions in night-time SBP standard deviations (SDs) (14.7 ± 4.7vs. 12.5 ± 3.9, p = 0.029) were observed at 12 weeks compared to baseline. OBPs significantly dropped from 151.1 ± 9.7/89.3 ± 8.3mmHg to 125.5 ± 13.8/77.8 ± 8.8mmHg after 12 weeks of SPC therapy (p < 0.001). Reductions in PPs of OBP and baPWVs were also observed. OLM/AML SPC therapy effectively reduced the 24-h mean BP, as measured by ABPM, in hypertensive patients over 55 years old who failed to achieve a target SBP (< 140mmHg) with angiotensin receptor blocker (ARB) monotherapy using valsartan 80mg or candesartan 8mg. Trial Registration: ClinicalTrials.gov identifier: NCT01713920.

Prevalence and prediction of masked uncontrolled hypertension in patients recently hospitalised for an acute coronary syndrome

Abstract Background Masked uncontrolled hypertension (MUCH) is defined as normal office blood pressure (BP) but elevated out-of-office BP in patients on antihypertensive treatment. MUCH is associated with similar cardiovascular risk as sustained hypertension and is clinically challenging since this often remains undetected without out-of-office BP measurements. Purpose To study the prevalence of MUCH following an acute coronary syndrome and to utilise machine learning methods to develop prediction models for identifying MUCH. Methods Ambulatory 24-h BP measurement (ABPM) was performed in 100 patients attending the cardiology outpatient clinic at a Swedish university hospital following an acute coronary syndrome, as part of a study which screened for co-morbidities. From the SWEDEHEART registry, 106 variables during the hospital care period and subsequent follow-up visit (after 6-10 weeks) were pre-processed including filtering on 5 or more missing values and zero or near-zero variance. Variable importance for the prediction of MUCH (office BP &amp;lt; 140/90 mm Hg at ABPM start but mean 24-h BP ≥ 130/80 mm Hg) was assessed using the Boruta and least absolute shrinkage and selection operator (LASSO) machine learning algorithms. Subsequently, logistic regression, LASSO and random forest models using different variable subsets were evaluated by receiver operating characteristic area under the curve (AUC) in repeated cross-validation. Results Age was 62.0±8.4 years, 74% male, 54% had NSTEMI and 46% STEMI. The follow-up visit and ABPM were performed at median 7 and 11 weeks, respectively, after hospital discharge. Among 90 patients with complete data and ABPM recordings, 31 had mean 24-h BP above target levels, of which 18 were identified with MUCH. Patients with MUCH had lower eGFR (68±11 vs 76±12 ml/min/1.73m², P=0.009), and more often a history of hypertension (89 vs 53%, P=0.005) and diabetes mellitus (44 vs 11%, P=0.003). In total, 65 variables where eligible for machine learning after filtering. Boruta and LASSO identified pulse pressure at the follow-up visit, serum creatinine, diabetes mellitus and history of hypertension as important predictors. Random forest, logistic regression and LASSO showed mean AUC 0.826, 0.822, and 822, respectively, in cross validation using these predictors. Conclusions In this small trial, one in five had MUCH at follow-up after an acute coronary syndrome, which highlights the importance of out-of-office BP measurements. The easily accessible measures of pulse pressure at the follow-up visit, serum creatinine, diabetes mellitus and history of hypertension were identified as important predictors of MUCH. A simple prediction model may be used as a clinical decision support tool after appropriate external validation.

The association of obesity and hyperuricemia with ambulatory blood pressure in children.

Primary hypertension (HTN) in children is on the rise and linked to the childhood obesity epidemic. Recent studies support the role of hyperuricemia in the pathogenesis of HTN. With this study we intend to evaluate the effect of body mass index (BMI) and uric acid levels on daily blood pressure (BP) parameters/phenotypes and target organ damage (TOD). A mean ambulatory systolic and/or diastolic BP ≥ 95th percentile or above the adolescent cut points was defined as 'HTN'. Patients were grouped as group 1 normal weight, and group 2 overweight/obese. Of the 140 children (89 male/51 female) with a mean age of 13.9 ± 2.6years, 21 were overweight and 86 were obese. Mean 24-h systolic BP (SBP) and daytime SBP were higher in group 2 (p = 0.015, p = 0.011). BMI was positively correlated with 24-h SBP (r = 0.272, p = 0.001) and daytime SBP (r = 0.280, p = 0.001). Uric acid level showed a moderate correlation with daytime SBP (r = 0.311, p < 0.01). Logistical regression analysis showed that daytime SBP is independently associated with obesity (OR 7.44, 95%CI 2.7-20.6, p < 0.001) and male sex (OR 4.60, 95%CI 2.0-10.2, p < 0.001), but not uric acid. Left ventricular hypertrophy was more common in non-dippers (p = 0.044). Male sex and BMI are independently associated risk factors for systolic BP. The association between non-dipping pattern and TOD suggests the widespread use of ambulatory blood pressure monitoring (ABPM) in childhood HT. In this paper, we could not demonstrate an independent association between uric acid and SBP. The effect of uric acid on SBP seems to be regulated by other metabolic factors in addition to uric acid.

Masked uncontrolled hypertension among elderly black sub-saharan africans compared to younger adults: a cross-sectional in-hospital study

BackgroundAlthough aging and being of African descent are well-known risk factors for masked uncontrolled hypertension (MUCH), data on MUCH among elderly black sub-Saharan Africans (BSSA) are limited. Furthermore, it is unclear whether the determinants of MUCH in younger individuals differ from those in the elderly.ObjectiveThis study aimed to determine the prevalence and risk factors associated with MUCH in both elderly and younger BSSA individuals.MethodsIn this study, 168 patients with treated hypertension were assessed for medical history, clinical examination, fundoscopy, echocardiography, and laboratory data. All patients underwent ambulatory blood pressure (BP) monitoring for 24 h. MUCH was diagnosed if the average 24-h mean BP ≥ 130/80 mmHg, the daytime mean BP ≥ 135/85 mmHg, and/or the nighttime mean BP ≥ 120/70 mmHg, despite controlled clinic BP (≤ 140/90 mmHg). Logistic regression analysis was performed to assess independent factors associated with MUCH, including elderly and younger adults separately. P-values < 0.05 were used to indicate statistical significance.ResultsOf the 168 patients aged 53.6 ± 11.6 years, 92 (54.8%) were men, with a sex ratio of 1.2, and, 66 (39%) were aged ≥ 60 years. The proportion of patients with MUCH (27.4% for all patients) was significantly higher (p = 0.002) among elderly patients than among younger patients (45.5% vs. 15.7%). Diabetes mellitus (adjusted odds ratio [aOR], 2.44; 95% confidence interval [CI], 1.27–4.46; p = 0.043), anemia (aOR, 3.18; 95% CI, 1.07–5.81; p = 0.043), hypertensive retinopathy (aOR, 4.50; 95% CI, 1.57–5.4; p = 0.043), and left ventricular hypertrophy (aOR, 4.48; 95% CI, 2.26–8.35; p = 0.043) were independently associated with MUCH in the elderly. In younger individuals, male gender (aOR, 2.16; 95% CI, (1.33–4.80); p = 0.029), obesity (aOR, 3.02; 95% CI, (1.26–5.32); p = 0.001), and left ventricular hypertrophy (LVH) (aOR, 3.08; 95% CI, (2.14–6.24); p = 0.019) were independently associated with MUCH were independently associated with MUCH.ConclusionMUCH is more prevalent among elderly than among younger BSSA individuals. Determinants of MUCH vary by age. MUCH prevention and management strategies should be age-specific.

Abstract P325: Additive effect of nighttime blood pressure on left ventricular strain in patients with primary aldosteronism evaluated via cardiac magnetic resonance tissue tracking

Background: Primary aldosteronism (PA) induces left ventricular (LV) remodeling and increases the risk of high nighttime blood pressure (BP), which causes further heart damage. This study aimed to investigate whether nighttime BP aggravates LV deformation dysfunction and to identify independent factors affecting the global peak strain (PS) of LV remodeling in patients with PA compared to patients with essential hypertension (EH). Methods: A total of 280 patients with PA and 280 age- and sex-matched patients with EH who underwent cardiac magnetic resonance examination at the First Affiliated Hospital of Chengdu Medical College were included. According to the results of adrenal computed tomography and/or adrenal venous sampling, there were 154 patients with aldosterone-producing adenoma (APA) and 126 patients with idiopathic hyperaldosteronism (IHA). Twenty-four-hour ambulatory BP monitoring (ABPM), LV function, global strain parameters, and other clinical medical data were compared, and multivariate analysis was performed to identify the independent indicators of the LV PS. Results: No differences in age, sex, body mass index, clinical BP, 24-h mean BP, daytime BP, or duration of hypertension were found between the groups. Nighttime systolic BP (132 ± 17 vs. 126 ± 18 mm Hg, P &lt; 0.05) and diastolic BP (85 ± 11 vs. 80 ±10 mm Hg, P &lt; 0.05) were greater in PA patients than in EH patients. Compared with the EH controls, the PA patients had a lower LV global PS and peak diastolic strain rate (PDSR) in three directions. No significant differences were found in the PS (radial or longitudinal) or PDSR in the three directions between the APA and IHA groups. Furthermore, nighttime BP was an independent predictor of LV global radial, circumferential, and longitudinal PS. Conclusions: High nighttime BP may aggravate LV stiffness in patients with PA, resulting in decreased LV strain and function. Nighttime BP was independently correlated with LV global PS in patients with PA.

TYG INDEX AS PREDICTOR OF METABOLIC SYNDROME IN YOUNG TO-MIDDLE AGE STAGE I HYPERTENSIVES, UNTREATED AT THE BASELINE

Objective: Tyg index, a surrogate marker of insulin resistance, was shown to be a predictor of development of metabolic syndrome (MS) among diabetes patients and general population while the predictive value among young hypertensives is less known. The aim of the present study was to investigate the predictive capacity of tyg index for incident MS among young untreated hypertensives. Design and method: we investigated 949 young-to-middle age stage I hypertensives from the HARVEST study, mean age 32.4±8.7 years, mean BMI 24.7±3.2 kg/m2, 69.2% males, without MS at baseline. Mean 24h blood pressure (BP) at entry 130.0±10.9/81.0±8.3 mmHg. Tyg index was calculated according to the usual formula. Patients were divided into tyg quintiles:7.008-7.895, 7.896-8.199, 8.200-8.423, 8.424-8.585, &gt;=8.586 respectively. The risk of MS was calculated by means of survival Cox analyses adjusted for several confounders. Results: Patients in the highest quintiles were significantly older 35.3±8.1 years and heavier 25.3±3.3 kg/m2 than the bottom ones (p&lt;0.001). Also baseline metabolic parameters were worse in top quintile (serum glucose 96.2±14.1, uric acid 5.3±1.2 mg/dl, total cholesterol 212.1±35.3 mg/dl, HDL 51.8±10.2 mg/dl) in comparison to the lower ones (p&lt;0.001 for all comparisons). Baseline 24h BP values did not differ according to Tyg quintile, while heart rate was higher in the top quintile (74.3±8.4 bpm, p&lt;0.001). During 8.1 years of follow-up, 76.3% of subjects developed new onset MS. Again, metabolic parameters were worst in the highest tyg quintile (serum glucose 97.9±15.4 mg/dl, total cholesterol 225.9±44.7 mg/dl, and HDL 52.1±15.2 mg/dl, as was final BMI (26.2±3.6Kg/m2, p&lt;0.001 for all comparisons). Final 24h BP did not differ according to Tyg quintile while heart rate was higher in the highest quintile (p&lt;0.001). In multivariate Cox analysis patients in the 4th and 5th quintiles presented the highest risk of new onset MS (HR 1.51 (1.11-2.06) p=0.009; HR 1.46 (1.09-1.46)p=0.011, respectively), in comparison to the bottom quintile. Conclusions: The risk of development of metabolic syndrome was significantly increased among patients in the top tyg quintiles, confirming its predictive capacity as a surrogate marker of insulin resistance among young stage I hypertensives.

Abstract WP289: Insufficient Low-Frequency Blood Pressure Activity Under Orthostatic Stress Predicts Blunted Night-to-Day Blood Pressure Dipping in Patients With Ischemic Cerebrovascular Disease

Introduction: Blunted night-to-day blood pressure (BP) dipping was common in ischemic cerebrovascular disease (ICVD). BP dipping could be influenced by baroreflex, which stabilized BP by regulating sympathovagal balance. We sought to determine the relationship between baroreflex function and BP dipping in patients with ICVD. Methods: Patients with ICVD stable for at least 3 days were enrolled. Beat-to-beat BP and ECG were monitored in 3 phases of active standing [supine (S), supine to upright (SU), upright (U), 4 min each]. Baroreflex function was evaluated by time-domain and frequency-domain baroreflex sensitivity (BRS) and by indices of sympathovagal balance [low (0.04-0.15 Hz) to high (0.15-0.4 Hz) frequency ratio (LHR) of systolic BP (SBP) and RR interval (RRI)]. BP dipping was measured as percentage with 24h ambulatory BP monitoring. SBP dipping &lt;0 was defined as reverse BP dipping. Results: Among 66 patients, mean SBP dipping was 3.54% ± 6.85%. SBP dipping was positively related to BP-LHR SU (Spearman r=0.258, p=0.036), but had no significant correlation with time-domain and frequency-domain BRS, LHR S and LHR U of BP and RRI, or RRI-LHR SU (Table 1). Lower log BP-LHR SU was indicative of less SBP dipping [β (95% CI): 6.53 (1.67-11.40), p=0.009] and the presence of reverse BP dipping [OR (95% CI): 0.11 (0.02-0.65), p=0.015], even after adjusting age, sex, vascular risk factors, 24h mean BP level, NIHSS and mRS scores (Table 2). Conclusions: Low BP-LHR SU , which suggested sympathetic underactivation of BP activity during the orthostasis-stimulated baroreflex engagement, might be a pathophysiological link between baroreflex impairment and blunted BP dipping in ICVD.

Initial treatment with a single capsule containing half-dose quadruple therapy versus standard-dose dual therapy in hypertensive patients (QUADUAL): statistical analysis plan for a randomized, blinded, crossover trial

BackgroundCombined antihypertensive therapy has obvious advantages over single drug therapy. Hypertension guidelines fully affirm the efficacy of dual combination in initial antihypertensive therapy. Recent studies have also pointed out that the quadruple combination of very low-dose antihypertensive drugs is superior to single drugs. However, whether low-dose quadruple therapy is better than dual combination is unknown.Methods/designA randomized double-blind crossover clinical trial will be conducted to compare the efficacy and safety of low-dose quadruple antihypertensives (irbesartan 75 mg + metoprolol 23.75 mg + amlodipine 2.5 mg + indapamide 1.25 mg) with standard-dose dual antihypertensives (irbesartan 150 mg + amlodipine 5 mg) in the initial treatment of patients with mild to moderate hypertension (140–179/90–109 mmHg). Ninety patients are required and will be recruited and randomly assigned in a 1:1 ratio to two crossover groups. Two groups will receive a different combination therapy for 4 weeks, then switch to the other combination therapy for 4 weeks, with a 2-week wash-out. Antihypertensive effects and related adverse effects of the two antihypertensive combination treatments will be compared. The primary outcome, i.e., mean 24-h systolic blood pressure in ambulatory blood pressure monitoring, will be assessed via linear mixed-effects model.DiscussionThis statistical analysis plan will be confirmed prior to blind review and data lock before un-blinding and is sought to increase the validity of the QUADUAL trial.Trial registrationClinicalTrials.gov, NCT05377203. Registered May 11, 2022, https://clinicaltrials.gov/study/NCT05377203.

Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study

BackgroundA fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP monitoring (ABPM) may be a better predictor of cardiovascular disease risk than in-clinic BP. MethodsThis randomized, multicenter, double-blind study enrolled 565 adults with overweight/obesity. Inclusion criteria included participants willing to wear ABPM device for 24 h. Exclusion criteria included screening blood pressure >140/90 mmHg and antihypertensive medications not stable for 3 months prior to randomization. Participants received placebo (n = 184), phentermine 30 mg; (n = 191), or PHEN 15 mg/TPM 92 mg; (n = 190). 24-hour ABPM was performed at baseline and at week 8. The primary endpoint was mean 24-h systolic BP (SBP) as measured by ABPM, in the per protocol population. ResultsParticipants were mostly female (73.5 ​%) and White (81.6 ​%), with a mean age of 53.4 years; 32.4 ​% had no hypertension diagnosis or treatment, 62.5 ​% had hypertension using 0 to 2 antihypertensive medications, and 5.1 ​% had hypertension using ≥ 3 antihypertensive medications. Baseline mean SBP/diastolic BP (DBP) was 123.9/77.6 ​mmHg. At week 8, mean SBP change was −0.1 ​mmHg (placebo), +1.4 ​mmHg (phentermine 30 ​mg), and −3.3 ​mmHg (PHEN/TPM). Between-group difference for PHEN/TPM versus placebo was −3.2 ​mmHg (95 ​% CI: -5.48, -0.93 ​mmHg; p ​= ​0.0059). The between-group difference for PHEN/TPM versus phentermine 30 ​mg was −4.7 ​mmHg (95 ​% CI: −6.96, −2.45 ​mmHg; p ​< ​0.0001). Common (>2 ​% in any treatment group) adverse events (i.e., dry mouth, constipation, nausea, dizziness, paresthesia, dysgeusia, headache, COVID-19, urinary tract infection, insomnia, and anxiety) were mostly mild or moderate. ConclusionsIn this randomized, multicenter, double-blind ABPM study, PHEN/ TPM reduced SBP compared to either placebo or phentermine 30 mg (Funding: Vivus LLC; ClinicalTrials.gov: NCT05215418).

Effect of initial treatment with a single pill containing quadruple combination of quarter doses of blood pressure medicines versus standard dose monotherapy on ambulatory blood pressure indices

Abstract Background The QUARTET trial showed that a combination of four ultra-low-dose blood pressure (BP) medications lowered mean unattended office BP more effectively than initial monotherapy. Purpose To investigate the effects of a combination of four ultra-low-dose blood pressure (BP) medications on ambulatory BP changes. Methods Australian adults (≥18 years) with hypertension who were untreated or on monotherapy were eligible for participation in the QUARTET study. Overall, 591 participants were randomly assigned to receive either the quadpill (containing irbesartan 37.5 mg, amlodipine 1.25 mg, indapamide 0.625 mg, and bisoprolol 2.5 mg) or an indistinguishable monotherapy control (irbesartan 150 mg). The difference in 24-hour, daytime and night-time systolic and diastolic ambulatory BP at 12 and 52 weeks were pre-defined secondary outcomes. Reported parameters for this analysis were derived from ambulatory BP recordings of 576 participants that fulfilled pre-defined validation criteria. Results Of 576 participants, 289 were randomized to the quadpill group and 287 to the monotherapy group. At baseline, 24-h systolic/diastolic BP was 139.2/81.0 mmHg in the monotherapy vs. 139.8/81.3 in the quadpill group, daytime BP was 142.5/83.5 vs 143.4/84.0 mmHg, and night-time BP was 125.1/70.7 vs. 125.4/70.7 mmHg. At 12 weeks, mean 24-h ambulatory systolic and diastolic BP were 7.7 (95%CI: 9.6, 5.8) and 5.3 (95%CI: 6.5, 4.1) mmHg lower in the quadpill versus monotherapy group (p&amp;lt;0.001 for both). Similar reductions were observed for daytime (8.1/5.7 mmHg lower in quadpill compared to montherapy group) and night-time (6.3/4.0 mmHg lower in quadpill compared to monotherapy group) BP (all p&amp;lt;0.001) at 12 weeks. The reduction in systolic and diastolic ambulatory BP variability were more pronounced in the quadpill group at 12 weeks, the 24-h standard deviation was reduced by -1.2 (-1.8, -0.5) mmHg for systolic and -0.9 (-1.5, -0.4) mmHg diastolic BP. The rate of BP control (24 hours BP ≥130 and/or ≥80 mmHg) at 12 weeks was higher in the quadpill group (77% vs 50%; p&amp;lt;0.001). These effects were maintained at 52 weeks. Conclusion A quadruple quarter-dose combination compared to monotherapy resulted in greater ambulatory BP lowering across the entire 24-hour period with higher ambulatory BP control rates at both 12 and 52 weeks. These findings further substantiate the efficacy of an ultra-low-dose quadpill-based BP lowering strategy – which has been previously shown not to increase the rate of side effects - and extends it to ambulatory BP measurements.

Does COVID-19 Cause Non-Dıpper Hypertension?

Coronavirus disease 2019 (COVID-19) remains a health problem worldwide. The present study aimed to investigate the effect of blood pressure (BP) on the circadian pattern and prevalence of new-onset non-dipper hypertension in the post-COVID period in patients with known hypertension. This prospective single-center study included 722 patients hospitalized for COVID-19 infection. Ambulatory BP (ABP) data were collected during their initial hospitalization. The ABP data were reassessed 1month after the patients were discharged. The results were compared with a healthy control group with known hypertension but without COVID-19 infection. After exclusion criteria were applied, the study included 187 patients with COVID-19 and 136 healthy hypertensive controls. Post-COVID ABP showed that patients with COVID-19 had significantly higher mean 24-h systolic and diastolic BP, mean nighttime systolic and diastolic BP, and mean daytime diastolic BP than the control group. In addition, new-onset non-dipper hypertension was significantly higher in patients with COVID-19. This study demonstrated for the first time that the circadian pattern is disturbed and a non-dipper pattern develops in individuals with known hypertension during the post-COVID period.

Evaluation of cardiovascular risk factors in long-term survivors of adult- and childhood-onset brain tumours: a pilot study.

Survivors of childhood brain tumours (SCBT) and teenage and young adult cancer survivors have an adverse cardiovascular risk profile, which translates into an increased vascular mortality. Data on cardiovascular risk profiles in SCBT are limited, and furthermore, there are no data in adult-onset (AO) brain tumours. methods: Fasting lipids, glucose, insulin, 24-h blood pressure (BP), and body composition were measured in 36 brain tumour survivors (20 AO; 16 childhood-onset (CO)) and 36 age- and gender-matched controls. Compared with controls, patients had elevated total cholesterol (5.3 ± 1.1 vs 4.6 ± 1.0 mmol/L, P = 0.007), LDL-C (3.1 ± 0.8 vs 2.7 ± 0.9 mmol/L, P = 0.011), insulin (13.4 ± 13.1 vs 7.6 ± 3.3 miu/L, P = 0.014), and increased insulin resistance (homeostatic model assessment for insulin resistance (HOMA-IR) 2.90 ± 2.84 vs 1.66 ± 0.73, P = 0.016). Patients showed adverse body composition, with increased total body fat mass (FM) (24.0 ± 12.2 vs 15.7 ± 6.6 kg, P < 0.001) and truncal FM (13.0 ± 6.7 vs 8.2 ± 3.7 kg, P < 0.001). After stratification by timing of onset, CO survivors showed significantly increased LDL-C, insulin, and HOMA-IR compared with controls. Body composition was characterized by the increased total body and truncal FM. Truncal fat mass was increased by 84.1% compared with controls. AO survivors showed similar adverse cardiovascular risk profiles, with increased total cholesterol and HOMA-IR. Truncal FM was increased by 41.0% compared with matched controls (P = 0.029). No difference in mean 24-h BP was noted between patients and controls irrespective of the timing of cancer diagnosis. The phenotype of both CO and AO brain tumour survivors is characterized by an adverse metabolic profile and body composition, putatively placing long-term survivors at increased risk of vascular morbidity and mortality.

The Association between Diverticular Rebleeding and Early-Morning Blood Pressure and Surge: A Prospective Observational Trial

Introduction: Colonic diverticular bleeding is the major cause of lower gastrointestinal bleeding. Hypertension is a major risk factor for diverticular rebleeding. Direct evidence of an association between actual 24-h blood pressure (BP) and rebleeding is lacking. Therefore, we analyzed the association between 24-h BP and diverticular rebleeding. Methods: We performed a prospective observational cohort trial involving hospitalized patients with colonic diverticular bleeding. We performed 24-h BP measurements (ambulatory BP monitoring [ABPM]) in the patients. The primary outcome was diverticular rebleeding. We evaluated the 24-h BP difference and the morning and pre-awaking BP surge between rebleeding and non-rebleeding patients. Morning BP surge was defined as early-morning systolic BP minus the lowest night systolic BP >45 mm Hg (highest quartile of morning BP surge). The pre-awaking BP surge was defined as the difference between morning BP and pre-awaking BP. Results: Of 47 patients, 17 were excluded, leaving 30 who underwent ABPM. Of the 30 patients, 4 (13.33%) had rebleeding. The mean 24-h systolic and diastolic BP were 125.05 and 76.19 mm Hg in rebleeding patients and 129.98 and 81.77 mm Hg in non-rebleeding patients, respectively. Systolic BP at 5:00 (difference −23.53 mm Hg, p = 0.031) and 11:30 (difference −31.48 mm Hg, p = 0.006) was significantly lower in rebleeding patients than in non-rebleeding patients. Diastolic BP at 2:30 (difference −17.75 mm Hg, p = 0.023) and 5:00 (difference −16.12 mm Hg, p = 0.043) was significantly lower in rebleeding patients than in non-rebleeding patients. A morning surge was observed in one rebleeding patient and no non-rebleeding patients. The pre-awaking surge was significantly higher in rebleeding patients (28.44 mm Hg) than in non-rebleeding patients (9.30 mm Hg) (p = 0.015). Conclusion: Lower BP in the early-morning and a higher pre-awaking surge were risk factors for diverticular rebleeding. A 24-h ABPM can identify these BP findings and reduce the risk of rebleeding by enabling interventions in patients with diverticular bleeding.

Effect of air pollutants on ambulatory blood pressure

Background and methodologyAir pollutants have a significant impact on public health.The aim of the study was to find out the relationship between ambulatory blood pressure measured by 24-h ambulatory blood pressure monitoring (ABPM) and the atmospheric pollutants that are measured regularly (PM10, PM2.5, NO2 and SO2). An observational study of temporal and geographic measurements of individual patients (case-time series design) was carried out in Primary Care Centres and Hypertension Units in the Barcelona metropolitan area. We included 2888 hypertensive patients≥18 years old, untreated, with a first valid ABPM performed between 2005 and 2014 and with at least one air pollution station within a radius of <3km. Results and conclusionsThe mean age was 54.3 (SD 14.6) years. 50.1% were women and 16.9% of the sample were smokers. Mean 24-h blood pressure (BP) was 128.0 (12.7)/77.4 (9.7) mmHg. After adjusting for mean ambient temperature and different risk factors, a significant association was found between ambulatory diastolic BP (DBP) and PM10 concentrations the day before ABPM. For each increase of 10μg/m3 of PM10, an increase of 1.37mmHg 24-h DBP and 1.48mmHg daytime DBP was observed. No relationship was found between PM2.5, NO2 and SO2 and ambulatory BP, nor between any pollutant and clinical BP.The concentration of PM10 the day before the ABPM is significantly associated with an increase in 24-h DBP and daytime DBP.

ABILITY OF A CUFFLESS 24 HOUR AMBULATORY BLOOD PRESSURE MEASUREMENT DEVICE TO TRACK BLOOD PRESSURE CHANGES COMPARED TO A CUFF-BASED DEVICE

Objective: There is an increasing number of cuffless blood pressure (BP) measurement devices on the market. Beneath the absence of generally accepted validation protocols for these devices, the ability of these devices to track changes in BP levels over 24h in relation to an initial calibration BP is unknown. Aim of this study was to analyse this ability in a cuffless 24h BP device using pulse transit time. Design and method: We prospectively enrolled 166 participants for simultaneously performed cuffless (TestBP, Somnotouch NIBP) and cuff-based (RefBP, Spacelabs 90217A or IEM Mobil-o-graph) 24h BD measurements. Main exclusion criteria were atrial fibrillation or an inter-arm difference of &gt;10 mmHg. TestBP calibration was based on initial RefBP measurement (CalibBP). As surrogate parameters for tracking individual changes in BP levels after the CalibBP, we used the difference between CalibBP and mean 24h, awake and asleep BP measured by RefBP and TestBP. Additionally, we analysed the relationship between the difference of CalibBP and RefBP vs the difference between RefBP and TestBP. Results: Mean (±SD) age was 51.2 (15.1) years and 53% were male. Mean (±SD) difference between CalibBP and mean 24h BP by RefBP / TestBP were 7.4 (13.2) versus 1.8 (8.3) mmHg for systolic (p &lt; 0.0001) and 6.6 (6.8) versus 1.6 (5.8) mmHg for diastolic (p &lt; 0.0001). Corresponding ranges for CalibBP-RefBP were -35 – 55 mmHg vs. -14 – 34 for CalibBP-Test BP. Figure 1 shows a near linear relationship between the difference between CalibBP and RefBP and the difference between RefBP and TestBP for systolic and diastolic BP values. Red line indicates the theoretical situation that TestBP follows CalibBP without tracking changes in BP levels, green line an ideal agreement of RefBP and TestBP. Conclusions: This is the first study to show the lower ability of the cuffless BP device to track changes of BP levels after an initial calibration measurement compared to a standard cuff-based device over 24h. Additionally, the difference between the RefBP and the TestBP was nearly linearly associated with the difference between a CalibBP and the changes of the BP level.

DIETARY SODIUM RESTRICTION REDUCES NOCTURNAL BLOOD PRESSURE IN PATIENTS WITH TREATMENT RESISTANT HYPERTENSION

Objective: Patients with treatment resistant hypertension (TRH) are characterised by lack of blood pressure (BP) control despite antihypertensive treatment. They are at particular risk of cardiovascular disease and more likely to experience BP increase as a response to sodium loading than other individuals. In this study, we aimed to analyse if self-performed dietary sodium restriction could be implemented in patients with TRH. Moreover, we aimed to analyse the effect of this on nocturnal and 24h BP, and how BP changes were correlated to changes in plasma levels of BNP, nitric oxide and body water content. Design and method: The study was conducted as an interventional cross-over study including patients with TRH from 20-70 years. Patients were screened with 24h ambulatory BP monitoring initiated after observed intake of usual antihypertensive medication. They were included if 24h systolic BP&gt;130/80 mmHg. Study participation included two periods of 14 days; a standard period with usual diet and an interventional period with instructed dietary sodium restriction and handed-out sodium-free bread. At the end of each period, patients were examined with 24h BP monitoring, 24h urine collection (sodium excretion), blood samples (nitric oxide, BNP), and bioimpedance measurement (body water content). Results: Participation was completed by 15 patients with mean age 59 years and mean 24h BP 144/82 mmHg. Mean baseline urinary sodium excretion was 192(86) mmol/24h (11.2 grams of salt). As seen in Table 1, sodium excretion was reduced to 91 mmol/24h equalling 5.3 grams of salt. BP levels were reduced significantly. Plasma levels of nitric oxide increased significantly, and this was correlated to the change in 24h BP. Total body water content and plasma levels of BNP was reduced significantly. The changes in BP were not correlated to changes in sodium excretion, body water or BNP. Conclusions: Self-performed dietary sodium restriction could be implemented resulting in a significant reduction in BP levels. BP change was not related to changes in body water or sodium excretion. Increased levels of nitric oxide may be evidence of improved endothelial function and may be one of the involved mechanisms in BP decrease following sodium restriction

Long-term safety and efficacy of renal sympathetic denervation in atrial fibrillation: 3-year results of the AFFORD study

BackgroundAtrial fibrillation (AF) is the most common sustained arrhythmia which has been associated with increased sympathetic nervous system activity and hypertension. Recent evidence indicated that renal sympathetic denervation (RDN) could safely contribute to an improvement in AF burden.ObjectiveTo investigate the long-term safety and efficacy of radiofrequency RDN in hypertensive patients with symptomatic AF.MethodsThis pilot study included patients with symptomatic paroxysmal or persistent AF (European Hearth Rhythm Association class ≥ II) despite optimal medical therapy, office systolic blood pressure (BP) ≥ 140 mmHg and ≥ 2 antihypertensive drugs. AF burden was measured using an implantable cardiac monitor (ICM), implanted 3 months prior to RDN. ICM interrogation and 24-h ambulatory BP monitoring were performed at baseline and at 3/6/12/24/36 months post RDN. The primary efficacy outcome was daily AF burden. Statistical analyses were performed using Poisson and negative binomial models.ResultsA total of 20 patients with a median age [25th–75th percentiles] of 66.2 [61.2–70.8] years (55% female) were included. At baseline, office BP ± standard deviation (SD) was 153.8/87.5 ± 15.2/10.4 mmHg, while mean 24-h ambulatory BP was 129.5/77.3 ± 15.5/9.3 mmHg. Baseline daily AF burden was 1.4 [0.0–10.9] minutes/day and throughout a 3-year follow-up period, no significant change was observed (− 15.4%/year; 95% confidence interval (CI) − 50.2%, + 43.7%; p = 0.54). The number of defined daily doses of antiarrhythmic drugs and antihypertensive drugs remained stable over time, while mean 24-h ambulatory systolic BP decreased with − 2.2 (95% CI − 3.9, − 0.6; p = 0.01) mmHg/year.ConclusionsIn patients with hypertension and symptomatic AF, stand-alone RDN reduced BP but did not significantly reduce AF burden up until 3 years of follow-up.Graphical abstract