Combined Systolic-diastolic Hypertension Research Articles

Effect of renal denervation for patients with isolated systolic hypertension: a systematic review and meta-analysis.

Renal denervation (RDN) is a promising treatment based on catheter intervention for patients with refractory hypertension. However, the effect in patients with isolated systolic hypertension (ISH) remains controversial. The aim of this meta-analysis was to determine the blood pressure lowing effect of RDN in patients with ISH compared with combined systolic/diastolic hypertension (CH) patients. PubMed, Embase, Cochrane and ClinicalTrials.gov were searched for prospective clinical studies that included RDN. The outcomes of interest were the change of 24-hour ambulatory systolic blood pressure (SBP) from baseline. We used the fixed effects model to calculate weighted mean difference (WMD) with 95% confidence interval (CI). Six trials were included, with 1405 participants, including 597 patients with ISH and 808 patients with CH. Mean follow-up was five months. The reduction of 24-hour ambulatory SBP was significantly greater for the CH patients than the ISH patients (WMD = 3.89, 95% CI: 2.32-5.45, P < 0.0001). RDN also showed a greater reduction in office SBP in the CH patients compared to the ISH patients (WMD = 10.24, 95% CI: 4.24-15.74, P = 0.0003). And the effect was independent of age, length of follow-up, and ablation device. RDN provides superior blood pressure control in the CH patients compared with the ISH patients, and the CH patients may be the best suitable population for which RDN is indicated.

ISOLATED SYSTOLIC HYPERTENSION AND COMBINED SYSTOLIC-DIASTOLIC HYPERTEN-SION FOR PREDICTION OF NEW-ONSET DIABETES MELLITUS - DATA FROM A 8-YEAR-FOLLOW-UP STUDY

Objective: Isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension (CH) are related with increased cardiovascular risk, while new-onset diabetes mellitus (NOD) is linked with atherosclerosis progression. To compare the predictive role of ISH and CH for the incidence of NOD in a cohort of essential hypertensive patients. Design and method: We followed up 1435 non-diabetic essential hypertensives with office systolic blood pressure (BP)&gt; or = 140 mmHg [mean age 57 years, 730 males, office BP=153/92 mmHg] for a mean period of 8 years. All subjects had at least one annual visit and at baseline underwent echocardiographic study and blood sampling for estimation of metabolic profile. Patients with baseline ISH exhibited office systolic BP &gt; or =140 mmHg and office diastolic BP &lt;90 mmHg, while those with CH had office systolic BP &gt; or = 140 mmHg and office diastolic BP&gt; or =90 mmHg. Moreover, NOD was defined if at one or more of the follow-up visits a previously non-diabetic patient reported being on insulin or an oral hypoglycemic drug or if casual plasma glucose concentration &gt; or = 200 mg/dl or fasting glucose concentration &gt; or = 126 mg/dl or 2-h post load glucose &gt; or = 200 mg/dl during an oral glucose tolerance test. Results: The incidence of NOD over the follow-up period was 4.2% (n = 60). Patients with ISH (n = 460) compared to those with CH (n = 975) were older (65 ± 11 vs 54 ± 10 years, p &lt; 0.0001), had at baseline lower waist circumference (94.5 ± 11 vs 99 ± 13 cm, p &lt; 0.0001), office systolic BP (149 ± 12 vs 155 ± 13 mmHg, p &lt; 0.0001), office diastolic BP (80 ± 8 vs 98 ± 6 mmHg, p &lt; 0.0001), while did not differ regarding left ventricular mass index, glucose and lipid levels (p = NS for all). Univariate Cox regression analysis revealed that baseline ISH (hazard ratio = 2.143, p = 0.016) and CH (hazard ratio=1.272, p = 0.029) predicted NOD. However, in multivariate Cox regression model, CH did not turn out to be an independent predictor of NOD. Conclusions: In essential hypertensive patients, ISH but not CH exhibits independent prognostic value for NOD. These findings support that ISH constitutes a hypertensive phenotype of increased metabolic risk needing careful evaluation and treatment.

ISOLATED SYSTOLIC HYPERTENSION VERSUS COMBINED SYSTOLIC-DIASTOLIC HYPERTENSION AS PREDICTOR OF ATRIAL FIBRILATION: DATA FROM AN 8-YEAR-FOLLOW-UP STUDY

Objective: Isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension (CH) are related with increased cardiovascular risk. To compare the predictive role of ISH and CH for the incidence of atrial fibrillation (AF) in a cohort of essential hypertensive patients. Design and method: We followed up 1605 essential hypertensives with office systolic blood pressure (BP)&gt; or = 140 mmHg (mean age 58.1 years, 842 males, office BP = 153/92 mmHg) for a mean period of 8 years. All subjects had at least one annual visit and at baseline underwent echocardiographic study and blood sampling for estimation of metabolic profile. Patients with baseline ISH exhibited office systolic BP &gt; or = 140 mmHg and office diastolic BP &lt;90 mmHg, while those with CH had office systolic BP &gt; or = 140 mmHg and office diastolic BP &gt; or = 90 mmHg. Moreover, new-onset AF was defined as hospitalization for AF or compatible electrocardiographic tracings. Results: The incidence of new-onset AF over the follow-up period was 3.4% (n = 55). Patients with ISH (n = 510) compared to those with CH (n = 1095) were older (65 ± 10 vs 55 ± 11 years, p &lt; 0.0001), had at baseline lower waist circumference (95.5 ± 12 vs 98 ± 12 cm, p &lt; 0.0001), office systolic BP (149 ± 10 vs 155 ± 13 mmHg, p &lt; 0.0001), office diastolic BP (80 ± 5 vs 98 ± 7 mmHg, p &lt; 0.0001), while did not differ regarding left ventricular mass index and lipid levels (p = NS for all). Univariate Cox regression analysis revealed that baseline ISH (hazard ratio = 4.612, p = 0.013) and CH (hazard ratio = 1.794, p = 0.036) predicted new-onset AF. However, in multivariate Cox regression model, age (hazard ratio = 1.078, p &lt; 0.001), left ventricular mass index (hazard ratio 1.012, p = 0.014), left atrium diameter (hazard ratio = 1.102, p &lt; 0.001) and ISH (hazard ratio = 1.551, p = 0.035) but not CH turned out to be independent predictors of new-onset AF episodes. Conclusions: In essential hypertensive patients, ISH but not CH exhibits independent prognostic value for AF. These findings support that ISH constitutes a hypertensive phenotype of particularly increased arrhythmia risk needing careful evaluation and treatment.

Sex differences in the prevalence and hemodynamic profiles of hypertensive phenotypes: the HELIUS study

Abstract Background Based on systolic (SBP) and diastolic blood pressure (DBP), patients with hypertension can be classified into different phenotypes. Earlier studies have shown clear sex-differences in the relation between phenotype and cardiovascular outcomes, but large studies addressing underlying sex-differences in hemodynamics are lacking. Purpose To examine sex differences in the prevalence and underlying hemodynamic profile of different hypertensive phenotypes. Methods We used cross-sectional data of 22.112 individuals, 57.8% female, aged between 18–70 years from the HEalthy LIfe in an Urban Setting (HELIUS) study, an ongoing large multi-ethnic prospective cohort study. Based on office BP patients were classified as having: normal (NBP; SBP &amp;lt;140 mmHg and DBP &amp;lt;90 mmHg), isolated systolic hypertension (ISH; SBP ≥140 and DBP &amp;lt;90 mmHg), isolated diastolic hypertension (IDH; SBP &amp;lt;140 and DBP ≥90mmHg) or combined systolic diastolic hypertension (SDH; SBP ≥140 and DBP ≥90 mmHg). We explored sex differences in the prevalence hypertension and the distribution of phenotypes using chi-squared tests after stratification for age (young: &amp;lt;50, old: ≥50 years). In a subgroup of 11.046 participants, continuous non-invasive measurements of cardiac output (CO), stroke volume (SV), systemic vascular resistance (SVR) and mean arterial pressure (MAP) were obtained during 3–5 minutes with finger photoplethysmography in the supine position (Nexfin, Edwards Lifesciences, Irvine, CA, USA). Sex-differences between hemodynamic parameters were assessed using ANOVA tests of linear regression models correcting for age. Results In young participants, the overall prevalence of hypertension was significantly higher in men (19.7%) compared to women (11.4%), with a different distribution of phenotypes (both p&amp;lt;0.001). Amongst young hypertensive participants, SDH was the most prevalent phenotype in both men (46%) and women (52%), ISH had a prevalence of respectively 23% in men and 26% in women. In older subjects, overall prevalence of hypertension was 40.2% in men and 35.9% in women (p&amp;lt;0.001), with a different phenotypical distribution (p&amp;lt;0.001). SDH was the most predominant phenotype in men (50%), whilst ISH was the most prevalent phenotype in women (55%). Both young and old participants with ISH showed an elevated cardiac output, ranging from 0.38–0.47 ml/min compared to normotensives. Older men with SDH and IDH had both elevated SVR and CO, while older women had only an elevation in SVR (Figure 1). Conclusions There are important age-dependent sex-differences in the prevalence of hypertension, which translate into a different hemodynamic profile. The pattern of cardiac output alterations across phenotypes was different between older men and women, suggesting sex differences in the underlying pathophysiology of elevated blood pressure. These findings contribute to a better understanding of the pathogenesis of hypertension and could impact treatment responses. Funding Acknowledgement Type of funding source: Public grant(s) – EU funding. Main funding source(s): The Academic Medical Center (AMC) of Amsterdam and the Public Health Service of Amsterdam (GGD Amsterdam) provided core financial support for HELIUS. The HELIUS study is also funded by research grants of the Dutch Heart Foundation (Hartstichting; grant no. 2010T084), the Netherlands Organization for Health Research and Development (ZonMw; grant no. 200500003), the European Integration Fund (EIF; grant no. 2013EIF013) and the European Union (Seventh Framework Programme, FP-7; grant no. 278901).

ISOLATED SYSTOLIC HYPERTENSION VERSUS COMBINED SYSTOLIC-DIASTOLIC HYPERTENSION AS PREDICTOR OF ATRIAL FIBRILATION: DATA FROM AN 8-YEAR-FOLLOW-UP STUDY

Isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension (CH) are related with increased cardiovascular risk. The aim of the present study was to compare the predictive role of ISH and CH for the incidence of atrial fibrillation (AF) in a cohort of essential hypertensive

P6577Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of atrial fibrillation: data from a 8-year-follow-up study

Abstract Background/Introduction Isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension (CH) are related with increased cardiovascular risk. Purpose The aim of the present study was to compare the predictive role of ISH and CH for the incidence of atrial fibrillation (AF) in a cohort of essential hypertensive patients. Methods We followed up 1605 essential hypertensives with office systolic blood pressure (BP)≥140 mmHg [mean age 58.1 years, 842 males, office BP=153/92 mmHg] for a mean period of 8 years. All subjects had at least one annual visit and at baseline underwent echocardiographic study and blood sampling for estimation of metabolic profile. Patients with baseline ISH exhibited office systolic BP ≥140 mmHg and office diastolic BP &lt;90 mmHg, while those with CH had office systolic BP ≥140 mmHg and office diastolic BP ≥90 mmHg. Moreover, new-onset AF was defined as hospitalization for AF or compatible electrocardiographic tracings. Results The incidence of new-onset AF over the follow-up period was 3.4% (n=55). Patients with ISH (n=510) compared to those with CH (n=1095) were older (65±10 vs 55±11 years, p&lt;0.0001), had at baseline lower waist circumference (95.5±12 vs 98±12 cm, p&lt;0.0001), office systolic BP (149±10 vs 155±13 mmHg, p&lt;0.0001), office diastolic BP (80±5 vs 98±7 mmHg, p&lt;0.0001), while did not differ regarding left ventricular mass index and lipid levels (p=NS for all). Univariate Cox regression analysis revealed that baseline ISH (hazard ratio=4.612, p=0.013) and CH (hazard ratio=1.794, p=0.036) predicted new-onset AF. However, in multivariate Cox regression model, age (hazard ratio=1.078, p&lt;0.001), left ventricular mass index (hazard ratio 1.012, p=0.014), left atrium diameter (hazard ratio=1.102, p&lt;0.001) and ISH (hazard ratio=1.551, p=0.035) but not CH turned out to be independent predictors of new-onset AF episodes. Conclusions In essential hypertensive patients, ISH but not CH exhibits independent prognostic value for AF. These findings support that ISH constitutes a hypertensive phenotype of particularly increased arrhythmia risk needing careful evaluation and treatment.

P5469Isolated systolic hypertension and combined systolic-diastolic hypertension for prediction of new-onset diabetes mellitus: Data from a 8-year-follow-up study

Abstract Background/Introduction Isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension (CH) are related with increased cardiovascular risk, while new-onset diabetes mellitus (NOD) is linked with atherosclerosis progression. Purpose The aim of the present study was to compare the predictive role of ISH and CH for the incidence of NOD in a cohort of essential hypertensive patients. Methods We followed up 1435 non-diabetic essential hypertensives with office systolic blood pressure (BP)≥140 mmHg [mean age 57 years, 730 males, office BP=153/92 mmHg] for a mean period of 8 years. All subjects had at least one annual visit and at baseline underwent echocardiographic study and blood sampling for estimation of metabolic profile. Patients with baseline ISH exhibited office systolic BP ≥140 mmHg and office diastolic BP &lt;90 mmHg, while those with CH had office systolic BP ≥140 mmHg and office diastolic BP ≥90 mmHg. Moreover, NOD was defined if at one or more of the follow-up visits a previously non-diabetic patient reported being on insulin or an oral hypoglycemic drug or if casual plasma glucose concentration ≥200 mg/dl or fasting glucose concentration ≥126 mg/dl or 2-h post load glucose ≥200 mg/dl during an oral glucose tolerance test. Results The incidence of NOD over the follow-up period was 4.2% (n=60). Patients with ISH (n=460) compared to those with CH (n=975) were older (65±11 vs 54±10 years, p&lt;0.0001), had at baseline lower waist circumference (94.5±11 vs 99±13 cm, p&lt;0.0001), office systolic BP (149±12 vs 155±13 mmHg, p&lt;0.0001), office diastolic BP (80±8 vs 98±6 mmHg, p&lt;0.0001), while did not differ regarding left ventricular mass index, glucose and lipid levels (p=NS for all). Univariate Cox regression analysis revealed that baseline ISH (hazard ratio=2.143, p=0.016) and CH (hazard ratio=1.272, p=0.029) predicted NOD. However, in multivariate Cox regression model, age (hazard ratio=1.039, p&lt;0.001), baseline glucose levels (hazard ratio 1.011, p=0.016), waist circumference (hazard ratio=1.067, p&lt;0.001) and ISH (hazard ratio=1.651, p=0.029) but not CH turned out to be independent predictors of NOD. Conclusions In essential hypertensive patients, ISH but not CH exhibits independent prognostic value for NOD. These findings support that ISH constitutes a hypertensive phenotype of increased metabolic risk needing careful evaluation and treatment.

ISOLATED SYSTOLIC HYPERTENSION COMPARED TO COMBINED SYSTOLIC-DIASTOLIC HYPERTENSION AS PREDICTORS OF NEW-ONSET DIABETES MELLITUS

Objective:The aim of the study was to compare the predictive role of isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension (CH) for the incidence of new-onset diabetes mellitus (NOD) in essential hypertensive patients.Design and method:We followed up 1435 non-diabetic ess

Renal Denervation in Isolated Systolic Hypertension Using Different Catheter Techniques and Technologies.

Patients with isolated systolic hypertension (ISH) are thought to show a diminished blood pressure (BP)-lowering effect after renal sympathetic denervation (RDN). This conclusion is mostly derived from unipolar radiofrequency catheter ablation studies. Limited data for newer RDN technologies exist. We used data from the RADIOSOUND-HTN (Three-Arm Randomized Trial of Different Renal Denervation Devices and Techniques in Patients With Resistant Hypertension) comparing 3 different RDN approaches to investigate a possible interaction between ISH and RDN response. One hundred twenty patients were stratified by having ISH or combined systolic-diastolic hypertension (CH). Of these, 39 underwent radiofrequency ablation of the renal main arteries, 39 combined radiofrequency ablation of the main and branch arteries, and 42 were treated with ultrasound-based ablation of the main renal artery. Patients with ISH (n=61) were older and had lower systolic and diastolic BP on ambulatory measurement (ambulatory BP measurement) at baseline in comparison to CH (n=59). At 3 months, patients with ISH showed a less pronounced BP-lowering effect of RDN as compared to patients with CH (daytime average -5.9±11.8 versus -13.3±11.7 mm Hg, P=0.001). This difference was significant for radiofrequency ablation of the renal main arteries and ultrasound-based ablation of the main renal artery treatment but did not reach significance in the radiofrequency ablation of the main and branch arteries group. After adjustment for baseline BP values and age, there was no significant difference in BP reduction between ISH and CH. Using unadjusted BP values, RDN seems to be more effective in CH than in ISH. However, adjusting for baseline BP values revealed similar BP reduction in ISH and CH patients, irrespective of the RDN treatment used. The value of ISH as predictor for successful RDN might have been overestimated in the past. Clinical Trial Registration- URL: http://www.clinicaltrials.gov . Unique identifier: NCT02920034.

P6572Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of coronary artery disease and stroke: Data from a 8-year-follow-up study

P6572Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of coronary artery disease and stroke: Data from a 8-year-follow-up study

P6574Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of atrial fibrillation: Data from a 8-year-follow-up study

P6574Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of atrial fibrillation: Data from a 8-year-follow-up study

P4479Isolated systolic hypertension and combined systolic-diastolic hypertension for prediction of new-onset diabetes mellitus: Data from a 8-year-follow-up study

P4479Isolated systolic hypertension and combined systolic-diastolic hypertension for prediction of new-onset diabetes mellitus: Data from a 8-year-follow-up study

ISOLATED SYSTOLIC HYPERTENSION VERSUS COMBINED SYSTOLIC-DIASTOLIC HYPERTENSION AS PREDICTORS OF ATRIAL FIBRILLATION

Objective: The aim of the present study was to compare the predictive role of isolated systolic hypertension (ISH) and combined systolic-diastolic hypertension for the incidence of atrial fibrillation (AF) in essential hypertension. Design and method: We followed up 1605 essential hypertensives with office systolic blood pressure (BP) > or =140 mmHg [mean age 58.1 years, 842 males, office BP = 153/92 mmHg] for a mean period of 8 years. Patients with baseline ISH exhibited office systolic BP >or =140 mmHg and office diastolic BP <90 mmHg, while those with systolic-diastolic hypertension had office systolic BP > or =140 mmHg and office diastolic BP > or = 90 mmHg. Moreover, new-onset AF was defined as hospitalization for AF or compatible electrocardiographic tracings. Results: The incidence of new-onset AF over the follow-up period was 3.4% (n = 55). Patients with ISH (n = 510) compared to those with systolic-diastolic hypertension (n = 1095) were older (65 ± 10 vs 55 ± 11 years, p < 0.0001), had at baseline lower office systolic BP (149 ± 10 vs 155 ± 13 mmHg, p < 0.0001) and office diastolic BP (80 ± 5 vs 98 ± 7 mmHg, p < 0.0001), while did not differ regarding left ventricular mass index (p = NS). Univariate Cox regression analysis revealed that baseline ISH (hazard ratio = 4.612, p = 0.013) and systolic-diastolic hypertension (hazard ratio = 1.794, p = 0.036) predicted new-onset AF. However, in multivariate Cox regression model, age (hazard ratio = 1.078, p < 0.001), left atrium diameter (hazard ratio = 1.102, p < 0.001) and ISH (hazard ratio = 1.551, p = 0.035) but not systolic-diastolic hypertension turned out to be independent predictors of new-onset AF episodes. Conclusions: In hypertensive patients, ISH but not systolic-diastolic hypertension exhibits independent prognostic value for AF. These findings support that ISH constitutes a hypertensive phenotype of increased risk for AF needing careful management.

Endovascular ultrasound renal denervation to treat hypertension (RADIANCE-HTN SOLO): a multicentre, international, single-blind, randomised, sham-controlled trial

Early studies suggest that radiofrequency-based renal denervation reduces blood pressure in patients with moderate hypertension. We investigated whether an alternative technology using endovascular ultrasound renal denervation reduces ambulatory blood pressure in patients with hypertension in the absence of antihypertensive medications. RADIANCE-HTN SOLO was a multicentre, international, single-blind, randomised, sham-controlled trial done at 21 centres in the USA and 18 in Europe. Patients with combined systolic-diastolic hypertension aged 18-75 years were eligible if they had ambulatory blood pressure greater than or equal to 135/85 mm Hg and less than 170/105 mm Hg after a 4-week discontinuation of up to two antihypertensive medications and had suitable renal artery anatomy. Patients were randomised (1:1) to undergo renal denervation with the Paradise system (ReCor Medical, Palo Alto, CA, USA) or a sham procedure consisting of renal angiography only. The randomisation sequence was computer generated and stratified by centres with randomised blocks of four or six and permutation of treatments within each block. Patients and outcome assessors were blinded to randomisation. The primary effectiveness endpoint was the change in daytime ambulatory systolic blood pressure at 2 months in the intention-to-treat population. Patients were to remain off antihypertensive medications throughout the 2 months of follow-up unless specified blood pressure criteria were exceeded. Major adverse events included all-cause mortality, renal failure, an embolic event with end-organ damage, renal artery or other major vascular complications requiring intervention, or admission to hospital for hypertensive crisis within 30 days and new renal artery stenosis within 6 months. This study is registered with ClinicalTrials.gov, number NCT02649426. Between March 28, 2016, and Dec 28, 2017, 803 patients were screened for eligibility and 146 were randomised to undergo renal denervation (n=74) or a sham procedure (n=72). The reduction in daytime ambulatory systolic blood pressure was greater with renal denervation (-8·5 mm Hg, SD 9·3) than with the sham procedure (-2·2 mm Hg, SD 10·0; baseline-adjusted difference between groups: -6·3 mm Hg, 95% CI -9·4 to -3·1, p=0·0001). No major adverse events were reported in either group. Compared with a sham procedure, endovascular ultrasound renal denervation reduced ambulatory blood pressure at 2 months in patients with combined systolic-diastolic hypertension in the absence of medications. ReCor Medical.

P5458Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of coronary artery disease and stroke: Data from a Greek 8-year-follow-up study

P5458Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of coronary artery disease and stroke: Data from a Greek 8-year-follow-up study

P4450Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of new-onset diabetes mellitus: Data from a Greek 8-year-follow-up study

P4450Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of new-onset diabetes mellitus: Data from a Greek 8-year-follow-up study

P1728Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of atrial fibrillation: Data from a Greek 8-year-follow-up study

P1728Isolated systolic hypertension versus combined systolic-diastolic hypertension as predictors of atrial fibrillation: Data from a Greek 8-year-follow-up study

Reduced blood pressure-lowering effect of catheter-based renal denervation in patients with isolated systolic hypertension: data from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry.

AimsCatheter-based renal artery denervation (RDN) has been shown to lower blood pressure (BP) in certain patients with uncontrolled hypertension. Isolated systolic hypertension (ISH) (systolic BP [SBP] ≥140 mmHg and diastolic BP <90 mmHg), characterized by increased vascular stiffness, is the predominant hypertensive phenotype in elderly patients. This study compared baseline characteristics and SBP change at 6 months between patients with ISH and combined systolic–diastolic hypertension (CH).Methods and resultsThis study pooled data from 1103 patients from SYMPLICITY HTN-3 and the Global SYMPLICITY Registry. A total of 429 patients had ISH, and 674 had CH. Patients with ISH were significantly older than those with CH (66 vs. 55 years), had more type 2 diabetes mellitus (52.9 vs. 34.6%), and a lower estimated glomerular filtration rate (71.8 vs. 78.6 mL/min/1.73 m2); all P < 0.001. At 6 months, the SBP drop for CH patients was −18.7 ± 23.7 mmHg compared with a reduction of −10.9 ± 21.7 mmHg for ISH patients −7.8 mmHg, 95% confidence interval, CI, −10.5, −5.1, P < 0.001). The change in 24-h SBP at 6 months was −8.8 ± 16.2 mmHg in patients with CH vs. −5.8 ± 15.4 mmHg in ISH (−3.0 mmHg, 95% CI −5.4, −0.6, P = 0.015). Presence of ISH at baseline but not age was associated with less pronounced BP changes following the procedure. The strongest predictor of office SBP reduction at 6 months was CH, followed by aldosterone antagonist use and non-use of vasodilators.ConclusionThe reduction in BP among patients with ISH following RDN was less pronounced than the reduction in patients with CH.Clinical.Trials.gov identifiersNCT01534299 and NCT01418261.

The SPYRAL HTN Global Clinical Trial Program: Rationale and design for studies of renal denervation in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications

Renal sympathetic activation plays a key role in the pathogenesis of hypertension, as demonstrated by high renal norepinephrine spillover into plasma of patients with essential hypertension. Renal denervation has demonstrated a significant reduction in blood pressure in unblinded studies of hypertensive patients. The SYMPLICITY HTN-3 trial, the first prospective, masked, randomized study of renal denervation versus sham control, failed its primary efficacy end point and raised important questions around potentially confounding factors, such as drug changes and adherence, study population, and procedural methods. The SPYRAL HTN Global Clinical Trial Program is designed to address limitations associated with predicate studies and provide insight into the impact of pharmacotherapy on renal denervation efficacy. The 2 initial trials of the program focus on the effect of renal denervation using the Symplicity Spyral multielectrode renal denervation catheter in hypertensive patients in the absence (SPYRAL HTN OFF-MED) and presence (SPYRAL HTN ON-MED) of antihypertensive medications. The SPYRAL HTN ON-MED study requires patients to be treated with a consistent triple therapy antihypertensive regimen, whereas the SPYRAL HTN OFF-MED study includes a 3- to 4-week drug washout period followed by a 3-month efficacy and safety end point in the absence of antihypertensive medications. The studies will randomize patients with combined systolic-diastolic hypertension to renal denervation or sham procedure. Both studies allow renal denervation treatments in renal artery branches and accessories. These studies will inform the design of the second pivotal phase of the program, which will more definitively analyze the antihypertensive effect of renal denervation.

Coronary Microvascular Function in Patients With Isolated Systolic and Combined Systolic/Diastolic Hypertension

Isolated systolic hypertension (ISH) is a common condition in the elderly that is associated with endothelial dysfunction. Concerning the effect of type of hypertension on coronary microvascular function, coronary flow reserve (CFR) in patients with ISH was evaluated and the results were compared with patients with combined systolic/diastolic hypertension (SDH). Seventy-six elderly patients (older than 60 years) who were free of coronary artery disease and diabetes mellitus were enrolled in the study (38 with ISH and 38 with combined SDH). Using transthoracic Doppler echocardiography, CFR was calculated as the ratio of hyperemic to baseline diastolic peak flow velocities. A CFR value of >2 was accepted as normal. The mean age was 68.6±6.3 years and the groups had similar features with regard to demographic and clinical characteristics. Patients with ISH had significantly lower CFR values compared with those with combined SDH (2.22±0.51 vs 2.49±0.56, respectively; P=.03). On multivariate regression analysis, ISH (β=-0.40, P=.004) and dyslipidemia (β=-0.29, P=.04) were the independent predictors of CFR. These findings indicate that CFR, an indicator of coronary microvascular/endothelial function, is impaired more profoundly in patients with ISH than in patients with combined SDH.