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Effects of lifestyle modification on patients with resistant hypertension: results of the TRIUMPH randomized clinical trial [with consumer summary]
Blumenthal JA, Hinderliter AL, Smith PJ, Mabe S, Watkins LL, Craighead L, Ingle K, Tyson C, Lin P-H, Kraus WE, Liao L, Sherwood A
Circulation 2021 Oct 12;144(15):1212-1226
clinical trial
8/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

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) mmHg) compared with SEPA (-7.1 (-95% CI 10.4 to -3.7) mmHg) (p = 0.005); 24-hour ambulatory systolic BP also was reduced in C-LIFE (-7.0 (95% CI -8.5 to -4.0) mmHg), with no change in SEPA (-0.3 (95% CI -4.0 to 3.4) mmHg) (p = 0.001). Compared with SEPA, C-LIFE resulted in greater improvements in resting baroreflex sensitivity (2.3 ms/mmHg (95% CI 1.3 to 3.3) versus -1.1 ms/mmHg (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.
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