Mean 24-hour Ambulatory Blood Pressure Research Articles

Safety and Efficacy of Renal Denervation in Patients Taking Antihypertensive Medications

BackgroundRenal denervation (RDN) reduces blood pressure (BP) in patients with uncontrolled hypertension in the absence of antihypertensive medications. ObjectivesThis trial assessed the safety and efficacy of RDN in the presence of antihypertensive medications. MethodsSPYRAL HTN-ON MED is a prospective, randomized, sham-controlled, patient- and assessor-blinded trial enrolling patients from 56 clinical centers worldwide. Patients were prescribed 1 to 3 antihypertensive medications. Patients were randomized to radiofrequency RDN or sham control procedure. The primary efficacy endpoint was the baseline-adjusted change in mean 24-hour ambulatory systolic BP at 6 months between groups using a Bayesian trial design and analysis. ResultsThe treatment difference in the mean 24-hour ambulatory systolic BP from baseline to 6 months between the RDN group (n = 206; −6.5 ± 10.7 mm Hg) and sham control group (n = 131; −4.5 ± 10.3 mm Hg) was −1.9 mm Hg (95% CI: −4.4 to 0.5 mm Hg; P = 0.12). There was no significant difference between groups in the primary efficacy analysis with a posterior probability of superiority of 0.51 (Bayesian treatment difference: −0.03 mm Hg [95% CI: −2.82 to 2.77 mm Hg]). However, there were changes and increases in medication intensity among sham control patients. RDN was associated with a reduction in office systolic BP compared with sham control at 6 months (adjusted treatment difference: −4.9 mm Hg; P = 0.0015). Night-time BP reductions and win ratio analysis also favored RDN. There was 1 adverse safety event among 253 assessed patients. ConclusionsThere was no significant difference between groups in the primary analysis. However, multiple secondary endpoint analyses favored RDN over sham control. (SPYRAL HTN-ON MED Study [Global Clinical Study of Renal Denervation With the Symplicity Spyral Multi-electrode Renal Denervation System in Patients With Uncontrolled Hypertension in the Absence of Antihypertensive Medications]; NCT02439775)

Twenty-Four-Month Blood Pressure Results After Renal Denervation Using Endovascular Ultrasound.

BACKGROUND Renal denervation has proven its efficacy to lower blood pressure in comparison to sham treatment in recent randomized clinical trials. Although there is a large body of evidence for the durability and safety of radiofrequency-based renal denervation, there are a paucity of data for endovascular ultrasound-based renal denervation (uRDN). We aimed to assess the long-term efficacy and safety of uRDN in a single-center cohort of patients. METHODS AND RESULTS Data from 2 previous studies on uRDN were pooled. Ambulatory 24-hour blood pressure measurements were taken before as well as 3, 6, 12, and 24 months after treatment with uRDN. A total of 130 patients (mean age 63±9 years, 24% women) underwent uRDN. After 3, 6, 12, and 24 months, systolic mean 24-hour ambulatory blood pressure values were reduced by 10±12, 10±14, 8±15, and 10±15 mm Hg, respectively, when compared with baseline (P<0.001). Corresponding diastolic values were reduced by 6±8, 6±8, 5±9, and 6±9 mm Hg, respectively (P<0.001). Periprocedural adverse events occurred in 16 patients, and all recovered without sequelae. CONCLUSIONS In this single-center study, uRDN effectively lowered blood pressure up to 24 months after treatment.

RELATION BETWEEN WAIST CIRCUMFERENCE AND THE RENAL HEMODYNAMIC IN PATIENTS WITH UNCOMPLICATED HYPERTENSION GRADE 1-2

Objective: Abdominal adiposity, measured by waist circumference (WC), is associated with increased mortality in patients with hypertension. Little is known about the impact of abdominal obesity on the renal perfusion and function in patients with hypertension. We analyzed whether abdominal adiposity changes renal hemodynamics in 36 patients with uncomplicated hypertension grade 1-2 without other cardiovascular (CV) disease. Design and method: We analysed the renal hemodynamic using steady state input clearance with infusion of para-aminohippuric acid and inulin, respectively. Intraglomerular pressure and resistances of the afferent (RA) and efferent (RE) arterioles were calculated according to the Gomez equation. The study population was divided in into two groups based on median of WC of the total study population. Results: The study cohort consisted of 36 male, non-smoking individuals, aged 36 ± 10 years with mean WC of 96.1 ± 10.4 cm and mean BMI of 27 ± 3.8 kg/m2. True hypertension was confirmed using 24-hour ambulatory blood pressure (BP) measurement. Patients in the high WC group (19 patients) showed mean office BP of 145/ 90 mmHg and mean 24-hour ambulatory BP of 139/ 86 mmHg, whereas patients in the low WC group (17 patients) showed mean office BP of 144/ 88 mmHg and mean 24-hour-ambulatory BP of 140/ 86 mmHg (office BP: p = 0.895/ p = 0.662, 24-hour-ambulatory BP: p = 0.645/ p = 0.918). Renal vascular resistance and RA were higher in the high WC compared to the low WC group, whereas glomerular filtration rate and renal plasma flow were lower in the high WC compared to the low WC group (table 1). Conclusions: Higher WC in young, male patients with hypertension grade 1-2 without other cardiovascular disease was associated with increased renal vascular resistance predominantly at the afferent site leading to reduced glomerular filtration rate.

Effect of a Telephone Health Coaching Intervention on Hypertension Control in Young Adults

Uncontrolled hypertension (ie, a 24-hour ambulatory systolic blood pressure of ≥130 mm Hg and diastolic blood pressure of ≥80 mm Hg or clinic systolic blood pressure of ≥140 mm Hg and diastolic blood pressure of ≥90 mm Hg) in young adults is a US public health burden. To evaluate the effect of a telephone coaching and blood pressure self-monitoring intervention compared with usual care on changes in systolic and diastolic blood pressures and behaviors at 6 and 12 months. This randomized clinical trial included male and female participants aged 18 to 39 years with uncontrolled hypertension confirmed by 24-hour ambulatory blood pressure testing. This was a geographically diverse, multicentered study within 2 large, Midwestern health care systems. Data were collected from October 2017 to February 2022 and analyzed from February to June 2022. The My Hypertension Education and Reaching Target (MyHEART) intervention consisted of telephone coaching every 2 weeks for 6 months, with home blood pressure monitoring. Control participants received routine hypertension care. The co-primary clinical outcomes were changes in 24-hour ambulatory and clinic systolic and diastolic blood pressure at 6 and 12 months. The secondary outcomes were hypertension control (defined as ambulatory systolic blood pressure <130 mm Hg and diastolic blood pressure <80 mm Hg or clinic systolic blood pressure <140 mm Hg and diastolic blood pressure <90 mm Hg) and changes in hypertension self-management behavior. A total of 316 participants were randomized (159 to the control group and 157 to the intervention group) from October 2017 to December 2020. The median (IQR) age was 35 (31-37) years, 145 of 311 participants (46.6%) were female, and 166 (53.4%) were male; 72 (22.8%) were Black, and 222 (70.3%) were White. There were no differences in baseline characteristics between groups. There was no significant difference between control and intervention groups for mean 24-hour ambulatory systolic or diastolic blood pressure or clinic systolic or diastolic blood pressure at 6 or 12 months. However, there was appreciable clinical reduction in blood pressures in both study groups (eg, mean [SD] change in systolic blood pressure in intervention group at 6 months, -4.19 [9.77] mm Hg; P < .001). Hypertension control did not differ between study groups. Participants in the intervention group demonstrated a significant increase in home blood pressure monitoring at 6 and 12 months (eg, 13 of 152 participants [8.6%] checked blood pressure at home at least once a week at baseline vs 30 of 86 [34.9%] at 12 months; P < .001). There was a significant increase in physical activity, defined as active by the Godin-Shephard Leisure-Time Physical Activity Questionnaire, in the intervention group at 6 months (69 of 100 [69.0%] vs 51 of 104 [49.0%]; P = .004) but not at 12 months (49 of 86 [57.0%] vs 49 of 90 [54.4%]; P = .76). There was a significant reduction in mean (SD) sodium intake among intervention participants at 6 months (3968.20 [1725.17] mg vs 3354.72 [1365.75] mg; P = .003) but not 12 months. There were no significant differences in other dietary measures. The MyHEART intervention did not demonstrate a significant change in systolic or diastolic blood pressures at 6 or 12 months between study groups; however, both study groups had an appreciable reduction in blood pressure. Intervention participants had a significant reduction in dietary sodium intake, increased physical activity, and increased home blood pressure monitoring compared with control participants. These findings suggest that the MyHEART intervention could support behavioral changes in young adults with uncontrolled hypertension. ClinicalTrials.gov Identifier: NCT03158051.

PMON265 First Ever Placebo-Controlled Randomised Study of Testosterone on Ambulatory Blood Pressure and Heart Rate in Hypogonadal Men With Uncontrolled Type 2 Diabetes – STRIDE Study

Abstract Background Testosterone has been historically believed to increase blood pressure(BP) and hence bad for heart despite no convincing evidence to prove this. Self-administered use of anabolic steroids has adverse cardiac effects including hypertension. Many RCTs that have looked at the effect of TRT have been BP measurements using mercury sphygmomanometer. Our study is the first RCT looking at the effect of testosterone on ambulatory BP in patients with type 2 diabetes and hypogonadism. Research design and methods: This is a randomised double blinded placebo-controlled add-on trial of intramuscular testosterone undecanoate (Nebido®) administered every 12 weeks in 65 hypogonadal men with poorly-controlled diabetes. Phase 1 patients were randomly assigned to either treatment or placebo arm for 6 months of TRT. Phase 2 was an open-labelled phase for 6 months and patients on placebo moved on to the treatment group wherein patients in the treatment group continued. Diurnal Ambulatory-BP measurements were performed with Spacelabs 90217 mounted on the non-dominant upper arm over 24-hours. Results Mean age of the cohort was 59(42-77)years. 55.4% of the patients had hypertension at baseline. Baseline characteristics were comparable between active/placebo groups apart from cardiovascular disease and hypertension which were significantly higher in the active group compared to placebo group (n=28 vs n=18, p=0.05), (n=23 vs n=13, p=0.008) respectively. There was no significant difference in 24-hours ambulatory average SBP or DBP before and after TRT for 6 months (SBP p=0.407, DBP p=0.649). There were no significant changes in average daytime or night-time SBP (p=0.291), (p=0.295) respectively or average daytime DBP (p=0.566) or night-time DBP (p=0.879) either. There was no significant difference in the total average heart rate and day time average heart rate however night time average heart rate showed a significant reduction of around 4 beats/minute (p=0.046) between the two groups at 6 months. There was no significant difference in the values for the above parameters in the normotensive group (average baseline ambulatory BP≤ 140/90 mm of Hg) and hypertensive group (≥ to 140/90 mm of Hg) either. There was no change in antihypertensive medications in the first 6 months. Mean 24-hour ambulatory BP components were compared at 0, 3, 6, 9 and 12 months for participants in the active group before and after treatment with testosterone undecanoate. There was no significant change in the total, day or night-time systolic or diastolic BP levels before and after the treatment. Conclusions Our study concludes that testosterone given as a replacement hormone in hypogonadal patients with type 2 diabetes does not increase 24-hour ambulatory systolic or diastolic BP. Our study also shows that testosterone causes a decrease in average night-time heart rate of 4 to 5 beats/minute and the cause and significance of such a decrease needs further detailed evaluation. Presentation: Monday, June 13, 2022 12:30 p.m. - 2:30 p.m.

Renal artery stenosis presenting as hypertension with hypokalemia.

A 69-year-old woman was seen by her family physician with new-onset, asymptomatic hypertension and hypokalemia. Her physical examination was normal and her mean 24-hour ambulatory blood pressure was 220/110 mm Hg. Her serum creatinine level was 74 (normal 44–97) μmol/L, but her serum potassium

Chlorthalidone for Hypertension in Advanced Chronic Kidney Disease

BackgroundLittle evidence has been available to support the use of thiazide diuretics to treat hypertension in patients with advanced chronic kidney disease.MethodsWe randomly assigned patients with stage 4 chronic kidney disease and poorly controlled hypertension, as confirmed by 24-hour ambulatory blood-pressure monitoring, in a 1:1 ratio to receive chlorthalidone at an initial dose of 12.5 mg per day, with increases every 4 weeks if needed to a maximum dose of 50 mg per day, or placebo; randomization was stratified according to previous use of loop diuretics. The primary outcome was the change in 24-hour ambulatory systolic blood pressure from baseline to 12 weeks. Secondary outcomes were the change from baseline to 12 weeks in the urinary albumin-to-creatinine ratio, N-terminal pro–B-type natriuretic peptide level, plasma renin and aldosterone levels, and total body volume. Safety was also assessed.ResultsA total of 160 patients underwent randomization, of whom 121 (76%) had diabetes mellitus and 96 (60%) were receiving loop diuretics. At baseline, the mean (±SD) estimated glomerular filtration rate was 23.2±4.2 ml per minute per 1.73 m2 of body-surface area and the mean number of antihypertensive medications prescribed was 3.4±1.4. At randomization, the mean 24-hour ambulatory systolic blood pressure was 142.6±8.1 mm Hg in the chlorthalidone group and 140.1±8.1 mm Hg in the placebo group and the mean 24-hour ambulatory diastolic blood pressure was 74.6±10.1 mm Hg and 72.8±9.3 mm Hg, respectively. The adjusted change in 24-hour systolic blood pressure from baseline to 12 weeks was −11.0 mm Hg (95% confidence interval [CI], −13.9 to −8.1) in the chlorthalidone group and −0.5 mm Hg (95% CI, −3.5 to 2.5) in the placebo group. The between-group difference was −10.5 mm Hg (95% CI, −14.6 to −6.4) (P<0.001). The percent change in the urinary albumin-to-creatinine ratio from baseline to 12 weeks was lower in the chlorthalidone group than in the placebo group by 50 percentage points (95% CI, 37 to 60). Hypokalemia, reversible increases in serum creatinine level, hyperglycemia, dizziness, and hyperuricemia occurred more frequently in the chlorthalidone group than in the placebo group.ConclusionsAmong patients with advanced chronic kidney disease and poorly controlled hypertension, chlorthalidone therapy improved blood-pressure control at 12 weeks as compared with placebo. (Funded by the National Heart, Lung, and Blood Institute and the Indiana Institute of Medical Research; CLICK ClinicalTrials.gov number, NCT02841280.)

Long-Term Results up to 12 Months After Catheter-Based Alcohol-Mediated Renal Denervation for Treatment of Resistant Hypertension

[Figure: see text].

Abstract P154: Win Ratio Methodology Demonstrates Consistency Of Benefit Across Different Blood Pressure Reduction Thresholds Following Renal Denervation In The Spyral Htn-on Med Pilot Study

Objective: The win ratio is a statistical methodology to evaluate clinical trial outcomes using multiple hierarchical endpoints. We applied the win ratio to patients in SPYRAL HTN-ON MED pilot study to quantify potential differences in renal denervation (RDN) efficacy utilizing different blood pressure (BP) reduction thresholds. Methods: In the SPYRAL HTN-ON MED pilot study, patients were enrolled with office systolic BP (OSBP) ≥150 mmHg and &lt;180 mmHg, office diastolic BP ≥90 mmHg, and mean 24-hour ambulatory systolic BP (ASBP) ≥140 mmHg and &lt;170 mmHg despite 1 to 3 antihypertensive medications. Patients were randomized 1:1 to RDN or sham procedure. For the win ratio analysis, each RDN patient was compared with every sham control patient in the opposing group first according to ASBP to determine “win”, “lose” or “tie” with a threshold of 5 mmHg. Then, ties from the ASBP comparison underwent the comparison using OSBP with a threshold of 10 mmHg. Any tie for a pair comparing OSBP resulted in comparison of any reduction in anti-hypertensive medication burden. The win ratio analysis was repeated using thresholds of 3.5 mmHg for ASBP change, 5 mmHg for OSBP change and any net change in medication burden. Results: The calculated win ratio favored RDN: 2.78 (95% CI: 1.58, 5.48, p&lt;0.001), using thresholds of 5 mmHg for ASBP change, 10 mmHg for OSBP change, and any net change in medication burden, all at 6 months. To test the sensitivity of the analysis, the BP thresholds were changed to 3.5 mmHg for ASBP and 5 mmHg for OSBP, and the win ratio analysis was repeated, resulting in a win ratio again in favor of RDN of 2.68 [1.58, 5.00], p&lt;0.001. Conclusions: Win ratio methodology applied to the SPYRAL HTN-ON MED pilot study demonstrated that RDN was associated with a 2.6-2.8 times greater likelihood of BP or drug reduction compared with sham patients when evaluated across different BP reduction thresholds at 6 months.

Catheter-based alcohol-mediated renal denervation for the treatment of uncontrolled hypertension: design of two sham-controlled, randomized, blinded trials in the absence (TARGET BP OFF-MED) and presence (TARGET BP I) of antihypertensive medications

Arterial hypertension is a common and life-threatening condition and poses a large global health burden. Device-based treatments have been developed as adjunctive or alternative therapy, to be used with or without antihypertensive medication for treating uncontrolled hypertension. The safety and feasibility of chemical renal denervation (RDN) using the Peregrine Catheter and alcohol were demonstrated in a first-in-man and open-label clinical trials, prompting the initiation of the ongoing TARGET BP OFF-MED and TARGET BP I trials. The TARGET BP trials are randomized, blinded, sham-controlled trials designed to assess the safety and efficacy of alcohol-mediated RDN for the treatment of uncontrolled hypertension in the absence of antihypertensive medications (TARGET BP OFF-MED) or in addition to prescribed antihypertensive medications (TARGET BP I). Subjects with confirmed uncontrolled hypertension and suitable renal artery anatomy are randomized (1:1) to receive either RDN using the Peregrine Kit with alcohol (0.6mL per renal artery) infused through the Peregrine Catheter or diagnostic renal angiography only (sham procedure). TARGET BP OFF-MED completed enrollment and randomized 96 subjects. TARGET BP I will randomize approximately 300 subjects and will transition to an open-label safety cohort of approximately 300 subjects receiving RDN once the primary efficacy endpoint of the Randomized Controlled Trial (RCT) cohort has been met. Primary endpoints are change in mean 24-hour ambulatory systolic blood pressure from baseline to 8 weeks (TARGET BP OFF-MED) and 3months (TARGET BP I) post-procedure. The TARGET BP trials are the first large-scale, international, randomized trials aimed to investigate the safety and BP lowering efficacy of a novel RDN method, with perivascular alcohol delivery using the Peregrine Kit.

BILATERAL RENAL ARTERY EMBOLIZATION IN END-STAGE RENAL DISEASE AND RESISTANT HYPERTENSION

Objective: Some patients with end-stage renal disease present with resistant or refractory arterial hypertension despite dialysis and use of multiple antihypertensive drugs. Renal artery embolization is a rarely used minimally invasive interventional procedure which may provide improved blood pressure (BP) control in chronic renal parenchymal disease by eliminating renal function while avoiding the morbidity and mortality of a nephrectomy. Design and method: A 44-year old white male with chronic glomerulonephritis and stage 5 chronic kidney disease undergoing regular dialysis treatment was referred for refractory arterial hypertension. Despite treatment by 7 antihypertensive drugs and good therapeutic adherence his office and ambulatory BP remained very high. Plasma renin was markedly elevated and CT angiography found diffuse atherosclerotic changes of renal arteries. Sequential catheter-based renal artery embolization with application of a tissue glue was indicated. Results: In September 2019, catheter based embolization of right renal artery was performed in analgosedation, followed by the embolization of the left renal artery two weeks later. Because of the rapid antihypertensive effect of the procedure, antihypertensive medications were reduced at the time of the left-sided procedure (from 9 to 6 defined daily doses). One month after the renal artery embolization, despite reduced medication, office BP decreased from baseline 170/106 mmHg by 57/22 mmHg. Mean 24-hour, day-time and night-time ambulatory BP was reduced by 15/11 mmHg, 14/11 and 34/15 mmHg, respectively. The patient reported prolonged flank pain lasting approximately one week after the embolization, which responded well to conventional analgesics. Conclusions: Renal artery embolization lead to a marked improvement of BP control in a patient with end-stage renal disease, refractory arterial hypertension and high plasma renin. Further studies are warranted to assess the efficacy and safety of renal artery embolization in such patients.

NEW CONCEPT OF TRIGGER-SPECIFIC BLOOD PRESSURE SENSITIVITY “THERMOSENSITIVITY” MEASURED BY ICT-BASED MULTISENSOR ABPM IN PATIENTS WITH HEART FAILURE

Objective: A sudden elevation of blood pressure (BP) by cold temperatures in winter is widely recognized as one of causes in exacerbation of heart failure. A reactivity of BP against changes in temperature in ambulatory setting remains unclear in patients with heart failure. We assessed the BP reactivity against changes of temperature using a newly developed device ICT-based Multisensor Ambulatory BP Monitoring (IMS-ABPM) in patients with heart failure. Design and method: The IMS-ABPM has accelerometer, thermometer and atmospheric barometer, which enable to measure physical activity, temperature and atmospheric pressure with measuring ambulatory BP. In this study, we evaluated trigger-specific BP sensitivity according to the ambulatory BP reactivity based on the slope of BP change against the triggers using the IMS-ABPM, which was “thermosensitivity” defined as the slope of BP change against temperature in the BP measurement. This study was a cross-sectional study to assess relationship between “thermosensitivity” and cardiac function by using IMS-ABPM in patients who had been admitted to a medical facility due to heart failure. Results: Among 103 patients with heart failure (mean ± SD age, 76.4 ± 14.4 years; 47.6% men), 55.6% of patients was heart failure with preserved ejection fraction (HFpEF). Although mean 24-hour systolic BP level and ambulatory BP variability evaluated coefficient of variation, average real variability had not significant difference between patients with HFpEF and heart failure with reduced ejection fraction (HFrEF), the thermosensitivity was significantly lower (hyperthermosensitive) in patients with HFpEF compared to HFrEF (HFpEF, –1.59 ± 3.22 vs. HFrEF, 0.08 ± 4.14, p = 0.038). After adjusted age and sex, the thermosensitivity was significantly associated with HFpEF. Moreover, the thermosensitivity tended to be correlated with ejection fraction in echocardiography (r = –0.21, p = 0.052 in Spearman's correlation). Conclusions: Based on the results of this study, patients with HFpEF showed lower thermosensitivity (hyperthermosensitive), which suggested BP strongly elevated with cold temperature, compared to patients with HFrEF. The new concept of trigger-specific BP sensitivity “thermosensitivity” might be associated with the exacerbation of heart failure in HFpEF.

LONG-TERM EFFICACY AND SAFETY OF SPIRONOLACTONE IN THE TREATMENT OF RESISTANT ARTERIAL HYPERTENSION

Objective: Spironolactone is recommended as a fourth line antihypertensive drug by current hypertension guidelines. However, data about its long-term efficacy and safety is limited. Design and method: We prospectively followed 274 patients with resistant arterial hypertension who started treatment with spironolactone between September 2007 and December 2016. Change of office and ambulatory blood pressure (BP) between baseline and the last clinical examination was recorded, as well as the duration of spironolactone use, its dose, changes of other antihypertensive medications, laboratory parameters and the incidence of adverse events. Results: Patients were followed for an average of 35 (± 29) months, the mean daily dose of spironolactone was 27.5 mg. Mean office BP decreased during follow-up from 149/87 mmHg to 136/80 mmHg by a mean 13/7 mmHg (P &lt; 0.001 for both). Mean 24-hour, day-time and night-time ambulatory BP decreased by 12/6 mmHg, 11/6 mmHg and 14/9 mmHg respectively (P &lt; 0.001 for all). Adverse effects occurred in 72 patients (26.3%) and in 61 (22.2%) lead to discontinuation of spironolactone. Adverse events occurred more frequently in patients using angiotensin receptor blockers (hazard ratio – HR 1.65, P = 0.040), in the elderly (HR 1.38, P = 0.007) and patients with higher baseline serum creatinine (HR 1.12, P = 0.035). Conclusions: Our data confirm good long-term antihypertensive efficacy of spironolactone in patients who tolerate it. However, in more than a quarter of patients the use of spironolactone leads to side effects, which usually necessitate its discontinuation.

NO SIGNIFICANT DIFFERENCE SEEN IN QUALITY OF LIFE MEASURED BY SF-36 QUESTIONNAIRE BETWEEN PATIENTS WHO REACHED TARGET 24 HOUR BLOOD PRESSURE AND WHO DID NOT

Objective: To clarify if a difference is noticed in quality of life between Finnish drug-treated hypertensive patients who reached target daytime systolic and diastolic blood pressure (below 140/90 mmHg) compared to those who did not. Design and method: SF-36 quality of life questionnaire was filled out by 106 hypertensive patients (47 females, 59 males, aged 66.2 (7.5) years). All used at least one antihypertensive agent. 24 hour ambulatory blood pressure (ABPM) and pulse wave- velocity (PWV) were performed and laboratory tests taken. Sixty-four of the patients reached ABPM daytime systolic and diastolic blood pressure (&lt;140/90 mmHg) and 42 did not. Results: No significant difference was seen between the groups in any SF-36 quality of life parameters (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, mental health or the mean of them). The mean 24-hour ambulatory systolic blood pressure (SBP) was 142.9 (10.3) mmHg and diastolic blood pressure (DBP) 79.9 (7.1) mmHg in the patients who did not reach the target and 129.1 (7.7) mmHg and 77.4 (6.1) mmHg in the patients who reached (p = 0.0001). No significant difference was seen in age, weight, waist-hip ratio, carotid-femoral PWV, lipid values, GHbA1c or serum creatinine. Carotid-femoral PWV was 11.8 (3.8) and 11.5 (2.9) m/s. The mean (SD) of the eight SF-36 questionnaire scores was 71.8 (19.1) and 73.3 (19.8) (maximum 100). All SF-36 parameters correlated significantly (p &lt; 0.001) to each other. The high mean of the quality of life parameters correlated in the patients who did not reach the target to male gender, low 24-hour ABPM SBP standard deviation (SD), mean arterial BP SD, low daytime SBP SD and diastolic BP SD and mean BP SD. The high mean of the quality of life parameters correlated in the patients who reached the target to waist-hip ratio, type 1 diabetes mellitus, no change in carotid artery, low carotid-radial PWV and high 24-hour heart rate. Conclusions: The SF-36 scores of the Finnish drug-treated hypertensive patients did not differ markedly between those who reached blood pressure target and those who did not reach.

Automated office blood pressure is in agreement with awake and mean 24-hour ambulatory blood pressure at the lower blood pressure range.

Automated office blood pressure measurement eliminates the white coat effect and is associated with awake ambulatory blood pressure. This study examined whether automated office blood pressure values at lower limits were comparable to those of awake and mean 24-hour ambulatory blood pressure. A total of 552 patients were included in the study, involving 293 (53.1%) men and 259 (46.9%) women, with a mean age 55.0±12.5, of whom 36% were treated for hypertension. Both systolic and diastolic automated office blood pressures exhibited lower values compared to awake ambulatory blood pressure among 254 individuals with systolic automated office blood pressure <130mmHg (119±8mmHg vs 125±11mmHg, P<.0001 and 75±9mmHg vs 79±9mm Hg, P<.0001 for systolic and diastolic BPs, respectively). Furthermore, the comparison of systolic automated office blood pressure to the mean 24-hour ambulatory blood pressure levels also showed lower values (119±8 vs 121±10, P=.007), whereas the diastolic automated office blood pressure measurements were similar to 24-hour ambulatory blood pressure values. Our findings show that when automated office blood pressure readings express values <130/80mmHg in repeated office visits, further investigation should be performed only when masked hypertension is suspected; otherwise, higher automated office blood pressure values could be used for the diagnosis of uncontrolled hypertension, especially in individuals with organ damage.

Group-Based Care in Adults and Adolescents With Hypertension and CKD: A Feasibility Study

Rationale & ObjectiveGroup-based care provides an opportunity to increase patient access to providers without increasing physician time and is effective in the management of chronic diseases in the general population. This model of care has not been investigated in chronic kidney disease (CKD).Study DesignRandomized controlled trial in adults (n = 50); observational study in adolescents (n = 10).Setting & ParticipantsAdults and adolescents with CKD and hypertension in the Bronx, NY.InterventionGroup-based care (monthly sessions over 6 months) versus usual care in adults. All adolescents received group-based care and were analyzed separately.OutcomesParticipant attendance and satisfaction with group-based care were used to evaluate intervention feasibility. The primary clinical outcome was change in mean 24-hour ambulatory blood pressure. Secondary outcomes included physical activity, medication adherence, quality of life, and sodium intake as assessed by 24-hour urinary sodium excretion and food frequency questionnaires.ResultsAmong adults randomly assigned to group-based care, attendance was high (77% of participants attended ≥3 sessions) and most reported higher satisfaction. Mean 24-hour ambulatory systolic blood pressure decreased by −4.2 (95% CI, −13.3 to 5.8) mm Hg in group-based care patients compared with usual care at 6 months but this was not statistically significant. Similarly, we did not detect significant differences in health-related behaviors (such as medication adherence, sodium intake, and physical activity) or quality-of-life measures between the 2 groups. Among the adolescents, attendance was very poor; self-reported satisfaction, although high, did not change from baseline compared with the 6-month follow-up.LimitationsSmall study size, missing data.ConclusionsGroup-based care is feasible and acceptable among adults with hypertension and CKD. However, a larger trial is needed to determine the effect on blood pressure and health-related behaviors. Patient participation may limit the effectiveness of group-based care models in adolescents.FundingNational Institutes of Health R34 DK102174.Trial registrationhttps://clinicaltrials.gov/show/NCT02467894.

Plasma and Tissue Bioavailability and Blood Pressure Lowering Effects of Omega-3 Polyunsaturated Fatty Acids from Commonly Eaten, Naturally Enriched, Foods

AbstractGreater consumption of oily fish, and elevated plasma levels of the long-chain marine-derived omega-3 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), have been strongly and consistently associated with a reduced incidence of heart attacks, strokes, cognitive decline, Alzheimer's disease and cancers. Despite international guidelines recommending eating oily fish at least once per week (&gt; 250mg/day DHA and EPA), many people do not eat fish, and only a small minority of the world's population have optimal omega-3-PUFA plasma and tissue levels. Hence, in this project, we studied the bioavailability and blood pressure lowering effects of recently developed alternatives to oily fish, namely chicken-meat and eggs naturally enriched with algae-sourced omega-3-PUFAs.This was a double-blinded, controlled, randomised trial. Using a 2X2 factorial design, 161 healthy participants were randomized to eat at least 3 portions/week of omega-3-PUFA enriched (or control) chicken-meat, and to eat at least 3 omega-3-PUFA enriched (or control) eggs/week, for 6 months.Compared to control foods, eating enriched eggs, enriched chicken-meat and the combination for 6 months, resulted in plasma EPA increments (μg/g) of 3.1[2.8], 8.8[2.9]* &amp; 4.7[2.9], plasma DHA increments (μg/g) of 5.1[3.7], 9.3[3.8]* &amp; 13.1[3.9]*, and omega-3-index (sum of EPA + DHA as a percentage of total fatty acids in erythrocytes, %) increments of 0.9[0.3]*, 0.7[0.4]* &amp; 1.5[0.4]*, respectively. Mean 24-hour ambulatory blood pressure (systolic/diastolic, mmHg) declined with the enriched foods 0.3[1.3]/-0.2[1.0], -0.7[1.4]/-1.4[1.0], &amp; -1.9[1.4]/-2.9[1.0]*, respectively. Data provided as mean difference[SEM], and * denotes p &lt; 0.05.Regular consumption of omega-3-PUFA enriched chicken-meat and eggs resulted in statistically significant and clinically relevant increases in plasma and red cell levels of DHA and EPA. Both plasma and red cell bioavailability were similar to those previously described for oily fish. Furthermore, blood pressure, an important biomarker of cardiovascular health, decreased in those eating the omega-3-PUFA enriched foods. Omega-3-PUFA enriched chicken-meat and eggs offers consumers an attractive additional alternative to eating oily fish. Unlike many lifestyle interventions, long-term large population health benefits are not dependent on willingness of people to make long-lasting dietary changes, but on the widespread availability of a range of inexpensive, commonly eaten, naturally enriched foods.

Diagnostic Accuracy of Unattended Automated Office Blood Pressure Measurement in Screening for Hypertension in Kenya.

Despite increasing adoption of unattended automated office blood pressure (uAOBP) measurement for determining clinic blood pressure (BP), its diagnostic performance in screening for hypertension in low-income settings has not been determined. We determined the validity of uAOBP in screening for hypertension, using 24-hour ambulatory BP monitoring as the reference standard. We studied a random population sample of 982 Kenyan adults; mean age, 42 years; 60% women; 2% with diabetes mellitus; none taking antihypertensive medications. We calculated sensitivity using 3 different screen positivity cutoffs (≥130/80, ≥135/85, and ≥140/90 mm Hg) and other measures of validity/agreement. Mean 24-hour ambulatory BP monitoring systolic BP was similar to mean uAOBP systolic BP (mean difference, 0.6 mm Hg; 95% CI, -0.6 to 1.9), but the 95% limits of agreement were wide (-39 to 40 mm Hg). Overall discriminatory accuracy of uAOBP was the same (area under receiver operating characteristic curves, 0.66-0.68; 95% CI range, 0.64-0.71) irrespective of uAOBP cutoffs used. Sensitivity of uAOBP displayed an inverse association (P<0.001) with the cutoff selected, progressively decreasing from 67% (95% CI, 62-72) when using a cutoff of ≥130/80 mm Hg to 55% (95% CI, 49-60) at ≥135/85 mm Hg to 44% (95% CI, 39-49) at ≥140/90 mm Hg. Diagnostic performance was significantly better (P<0.001) in overweight and obese individuals (body mass index, >25 kg/m2). No differences in results were present in other subanalyses. uAOBP misclassifies significant proportions of individuals undergoing screening for hypertension in Kenya. Additional studies on how to improve screening strategies in this setting are needed.

1422Prevalence and characteristics of medication non-adherence assessed by quantitative liquid chromatography-tandem mass spectrometry in patients with hypertension

Abstract Background/Introduction Antihypertensive medication screening by qualitative high performance chromatography-tandem mass spectrometry (LC-MS/MS) has recently become available to detect non-adherence to antihypertensive treatment. Because the result of this test is dichotomous (the drug is detected or not), it may incorrectly classify patients who take their medications infrequently. Therefore, a quantitative screening method has been developed to improve detection of non-adherence. Purpose The aim of this study was to determine the prevalence of medication non-adherence assessed by quantitative LC-MS/MS in referred hypertensive patients. In addition, we determined to what extent clinical characteristics, prescribed medication and self-reported perspectives, were associated with medication non-adherence assessed by quantitative LC-MS/MS. Methods In this cross-sectional study we included 197 newly referred hypertensive patients (mean age 56±14 years, 101 women, mean 24-hour ambulatory blood pressure 143/85±21/12 mmHg) prescribed at least one antihypertensive drug. Medication adherence was assessed by quantitative LC-MS/MS in plasma. The concentration of each prescribed drug (or its metabolite) was measured and divided by the literature-based population trough concentration, to get the concentration ratio (CR). If the CR of at least one of the prescribed drugs was ≤0.3 the patient was categorized as non-adherent: completely non-adherent if all were ≤0.3, partially non-adherent if not all were ≤0.3. Logistic regression analysis was performed to determine the association between clinical characteristics, prescribed medication and self-reported compliance (Hill &amp; Bone), relational empathy (CARE) and beliefs about medicines (BMQ), and medication non-adherence. Results 29% was classified as partially non-adherent and 10% as completely non-adherent. Non-adherence to calcium antagonists (30%) and beta blockers (24%) prevailed non-adherence to other antihypertensive medication classes (6–11%). The odds of non-adherence were higher in patients with apparent resistant hypertension and increased with the number of antihypertensive medication types, tablets and daily defined dose prescribed (Figure 1). Combination pills were inversely associated with non-adherence. Self-reported measures were not associated. Older age was negatively associated with non-adherence to RAS inhibitors (OR 0.60, 95% CI 0.36–0.96) and beta blockers (OR 0.50, 95% CI 0.30–0.77). Figure 1 Conclusions Quantitative screening by LC-MS/MS in plasma shows a high prevalence of non-adherence in referred hypertensive patients, particularly for calcium antagonists and beta blockers. The observation that clinical characteristics and self-reported perspectives about medical treatment were not associated with non-adherence, supports the use of quantitative LC-MS/MS to detect non-adherence to antihypertensive medication in daily practice.

Effect and safety of LCZ696 in the treatment of hypertension

LCZ696 has been introduced in patients with hypertension in several trials. Here, we performed a meta-analysis to evaluate the effect and safety of LCZ696 in hypertensive patients. PubMed, Embase, the Cochrane Library and ClinicalTrials.gov databases were searched to identify the available randomized controlled trials (RCTs) investigating the effect and safety of LCZ696 in hypertension patients. The last search date was October 31, 2018. Nine RCTs with 6765 subjects were finally included, in which 8 trials compared the effect and safety between LCZ696 and angiotensin receptor antagonists (ARBs). Evidences showed LCZ696, compared with ARBs, achieved a better blood pressure control rate (OR 1.24, 95% CI: 1.14-1.35), specifically, LCZ696 were better at reducing systolic blood pressure [WMD -4.11 mmHg, 95% CI: (-5.13, -3.08) mmHg], diastolic blood pressure [WMD -1.79 mmHg, 95% CI: (-2.22, -1.37) mmHg], mean 24-hour ambulatory systolic blood pressure [WMD -3.24 mmHg, 95% CI: (-4.48, -1.99) mmHg] and mean 24-hour ambulatory diastolic blood pressure [WMD -1.25 mmHg, 95% CI: (-1.81, -0.69) mmHg]. There was no difference in the events of adverse events (risk ratio [RR] 1.01, 95% CI: 0.39-1.09), serious adverse events (RR 0.80, 95% CI: 0.52-1.22) and discontinuation of treatment for any adverse events (RR 0.79, 95% CI: 0.56-1.11) between LCZ696 group and ARB/placebo group, except LCZ696 reduced the rate of headaches (RR 0.69, 95% CI: 0.48-0.99) while increased cough (RR 2.12, 95% CI: 1.11-4.04; P = .02; I = 25%). Our finding provides evidence that LCZ 696 was more effective than ARB on blood pressure control and was safe enough in patients with hypertension.