Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial.

BACKGROUND: Resistant hypertension (RH) is a growing health burden in this country affecting as many as 1 in 5 adults being treated for hypertension. Resistant hypertension is associated with increased risk of adverse cardiovascular disease (CVD) events and all-cause mortality. Strategies to reduce blood pressure (BP) in this high-risk population are a national priority. METHODS: TRIUMPH is a single-site, prospective, randomized clinical trial to evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie Dietary Approaches to Stop Hypertension eating plan, and weight management compared to standardized education and physician advice in treating patients with RH. Patients (n = 150) will be randomized in a 2:1 ratio to receive either a 4-month supervised lifestyle intervention delivered in the setting of a cardiac rehabilitation center or to a standardized behavioral counseling session to simulate real-world medical practice. The primary end point is clinic BP; secondary end points include ambulatory BP and an array of CVD biomarkers including left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipids, sympathetic nervous system activity, and inflammatory markers. Lifestyle habits, BP, and CVD risk factors also will be measured at 1-year follow-up. CONCLUSIONS: The TRIUMPH randomized clinical trial (ClinicalTrials.gov NCT02342808) is designed to test the efficacy of an intensive, center-based lifestyle intervention compared to a standardized education and physician advice counseling session on BP and CVD biomarkers in patients with RH after 4 months of treatment and will determine whether lifestyle changes can be maintained for a year.

The long-term effects of lifestyle change on blood pressure: One-year follow-up of the ENCORE study.

BACKGROUND: There is a paucity of data describing the sustained benefits of lifestyle interventions on health behaviors and blood pressure (BP). METHODS: We examined the persistence of changes in health habits and BP in the ENCORE study, a trial in which 144 overweight individuals with above-normal BP were randomized to one of the following 16-week interventions: Dietary Approaches to Stop Hypertension (DASH) diet alone (DASH-A), DASH diet plus a behavioral weight management intervention (DASH-WM), or Usual Care. Follow-up assessments were conducted 8 months after the end of treatment. RESULTS: At 16 weeks, systolic BP was reduced by 16.1 (95% confidence interval (CI) = 13.0-19.2) mm Hg in the DASH-WM group, 11.2 (95% CI = 8.1-14.3) mm Hg in the DASH-A group, and 3.4 (95% CI = 0.4-6.4) mm Hg in the Usual Care group. A decrease in BP persisted for 8 months, with systolic BP lower than baseline by 11.7 (95% CI = 8.1-15.3) mm Hg in the DASH-WM group, 9.5 (95% CI = 6.7-12.1) mm Hg in the DASH-A group, and 3.9 (95% CI = 0.5-7.3) mm Hg in the Usual Care group (P < 0.001 for active treatments vs. Usual Care). DASH-WM subjects lost 8.7 kg during the intervention and remained 6.3 kg lighter on follow-up examination. Changes in diet content were sustained in both DASH intervention groups. Among those who participated in DASH-WM, however, caloric intake was no longer lower, and only 21% reported still exercising regularly 8 months after completing the intervention. CONCLUSIONS: Changes in dietary habits, weight, and BP persisted for 8 months after completion of the 16-week ENCORE program, with some attenuation of the benefits. Additional research is needed to identify effective methods to promote long-term maintenance of the benefits of lifestyle modification programs. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00571844.