Effects of Lifestyle Modification on Patients With Resistant Hypertension: Results of the TRIUMPH Randomized Clinical Trial

Abstract

Background: Although lifestyle modifications generally are effective in lowering blood pressure (BP) among patients with unmedicated hypertension and in those treated with 1 or 2 antihypertensive agents, the value of exercise and diet for lowering BP in patients with resistant hypertension is unknown.

Methods: One hundred forty patients with resistant hypertension (mean age, 63 years; 48% female; 59% Black; 31% with diabetes; 21% with chronic kidney disease) were randomly assigned to a 4-month program of lifestyle modification (C-LIFE [Center-Based Lifestyle Intervention]) including dietary counseling, behavioral weight management, and exercise, or a single counseling session providing SEPA (Standardized Education and Physician Advice). The primary end point was clinic systolic BP; secondary end points included 24-hour ambulatory BP and select cardiovascular disease biomarkers including baroreflex sensitivity to quantify the influence of the baroreflex on heart rate, high-frequency heart rate variability to assess vagally mediated modulation of heart rate, flow-mediated dilation to evaluate endothelial function, pulse wave velocity to assess arterial stiffness, and left ventricular mass to characterize left ventricular structure.

Results: Between-group comparisons revealed that the reduction in clinic systolic BP was greater in C-LIFE (-12.5 [95% CI, -14.9 to -10.2] mm Hg) compared with SEPA(-7.1 [-95% CI, 10.4 to -3.7] mm Hg) (P=0.005); 24-hour ambulatory systolic BP also was reduced in C-LIFE (-7.0 [95% CI, -8.5 to -4.0] mm Hg), with no change in SEPA (-0.3 [95% CI, -4.0 to 3.4] mm Hg) (P=0.001). Compared with SEPA, C-LIFE resulted in greater improvements in resting baroreflex sensitivity (2.3 ms/mm Hg [95% CI, 1.3 to 3.3] versus -1.1 ms/mm Hg [95% CI, -2.5 to 0.3]; P<0.001), high-frequency heart rate variability (0.4 ln ms² [95% CI, 0.2 to 0.6] versus -0.2 ln ms² [95% CI, -0.5 to 0.1]; P<0.001), and flow-mediated dilation (0.3% [95% CI, -0.3 to 1.0] versus -1.4% [95% CI, -2.5 to -0.3]; P=0.022). There were no between-group differences in pulse wave velocity (P=0.958) or left ventricular mass (P=0.596).

Conclusions: Diet and exercise can lower BP in patients with resistant hypertension. A 4-month structured program of diet and exercise as adjunctive therapy delivered in a cardiac rehabilitation setting results in significant reductions in clinic and ambulatory BP and improvement in selected cardiovascular disease biomarkers. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02342808.

Keywords: DASH diet; cardiac rehabilitation; exercise; hypertension; lifestyle.

Figure 1:

CONSORT chart of trial enrollment.

Figure 2:. Mean Baseline (Pre-) and Post-Treatment Clinic and 24-hour Ambulatory Blood Pressure by Treatment Group

Baseline (pre-treatment) and post-treatment unadjusted systolic and diastolic clinic blood pressure (left) and systolic and diastolic ambulatory blood pressure (right) by treatment group (C-LIFE in blue; SEPA in orange). Error bars represent standard errors.

Figure 3:. Mean Changes in Clinic and Ambulatory Blood Pressure from Baseline by Treatment Group

Adjusted mean systolic and diastolic blood pressure changes from baseline to post-treatment by treatment group. C-LIFE (blue) and SEPA (orange) plotted separately. Error bars represent standard errors.

Figure 4:. Individual changes in Clinic and 24-hour Ambulatory SBP for C-LIFE and SEPA groups

Individual systolic blood pressure (SBP) changes from baseline to post-treatment for clinic SBP (top) and ambulatory SBP (bottom) for C-LIFE (blue) and SEPA (orange).