Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial

Abstract

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.

Copyright © 2015 Elsevier Inc. All rights reserved.

Figures

Figure 1. Conceptual Model

depicts a model by which poor dietary habits and lack of physical activity may adversely impact BP in this population, and how the complex interplay of autonomic, metabolic, inflammatory, cardiac, and vascular function may be both a cause and consequence of RH. The TRIUMPH study is designed primarily to evaluate whether an intensive lifestyle intervention delivered in a CR setting can achieve clinically significant BP lowering in patients whose BP has failed to be adequately controlled by the combined effects of at least 3 antihypertensive medications. It is also designed to provide insight into whether diet and exercise improve comorbid disease and associated biomarkers of CVD risk in RH patients.

Figure 2. Study Design Overview