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/mmHg [95% CI, −2.5 to 0.3]; P<0.001), high-frequency heart rate variability (0.4 In ms² [95% CI, 0.2 to 0.6] versus -0.2 In 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.
Generated Summary
The TRIUMPH randomized clinical trial investigated the effects of a combined diet and exercise intervention, delivered in a cardiac rehabilitation setting, on patients with resistant hypertension. This study employed a randomized controlled trial design. One hundred forty patients with resistant hypertension were randomly assigned to either a 4-month structured program of lifestyle modification (C-LIFE), including dietary counseling, behavioral weight management, and exercise, or a single counseling session providing Standardized Education and Physician Advice (SEPA). The primary endpoint was clinic systolic blood pressure. Secondary endpoints included 24-hour ambulatory blood pressure and select cardiovascular disease biomarkers. The study aimed to determine the efficacy of lifestyle modifications, specifically exercise and diet, in lowering blood pressure in patients with resistant hypertension, a condition where blood pressure remains elevated despite treatment with multiple antihypertensive medications. The intervention was conducted in a cardiac rehabilitation setting, and participants were encouraged to maintain their prescribed antihypertensive medications throughout the study.
Key Findings & Statistics
- Participants: The study included 140 patients with resistant hypertension. The mean age was 63 years; 48% were female, 59% were Black, 31% had diabetes, and 21% had chronic kidney disease.
- Clinic Systolic Blood Pressure (SBP): The reduction in clinic systolic BP was greater in C-LIFE (-12.5 mm Hg [95% CI, -14.9 to -10.2]) compared with SEPA (-7.1 mm Hg [-9.5% CI, 10.4 to -3.7]) (P=0.005).
- 24-hour Ambulatory SBP: 24-hour ambulatory systolic BP was also reduced in C-LIFE (-7.0 mm Hg [95% CI, -8.5 to -4.0]), with no change in SEPA (-0.3 mm Hg [95% CI, -4.0 to 3.4]) (P=0.001).
- Baroreflex Sensitivity: C-LIFE resulted in greater improvements in resting baroreflex sensitivity (2.3 ms/mmHg [95% CI, 1.3 to 3.3] vs. -1.1 ms/mmHg [95% CI, -2.5 to 0.3]; P<0.001).
- High-Frequency Heart Rate Variability: C-LIFE also showed greater improvements in high-frequency heart rate variability (0.4 In ms² [95% CI, 0.2 to 0.6] vs. -0.2 In ms² [95% CI, -0.5 to 0.1]; P<0.001).
- Flow-Mediated Dilation: C-LIFE showed improvements in flow-mediated dilation (0.3% [95% CI, -0.3 to 1.0] vs. -1.4% [95% CI, -2.5 to -0.3]; P=0.022).
- Weight Loss: C-LIFE participants experienced substantial weight loss (-15.3 lb [95% CI, -17.2 to -13.3]) compared to SEPA (-8.5 lb [95% CI, -11.4 to -5.6]) (P<0.001).
- Dietary Adherence: Participants in C-LIFE attended a median of 94% of DASH diet classes (IQR, 81%, 94%) (mean = 88.4 [SD = 11.3]) and 89% of structured exercise sessions (IQR, 84%, 96%) (mean = 88.3 [SD = 11.6]).
- Aerobic Fitness: Improvements in peak VO₂ in the C-LIFE condition (14.8% VO₂ improvement [95% CI, 11.0 to 18.6]) compared with SEPA (3.4% VO₂ improvement [95% CI, -2.3 to 9.2]) (P=0.002).
- Medication Burden: There was no significant change in BP medication burden from baseline to after treatment (P=0.627), and no evidence of differential changes between treatment groups (P=0.842).
Other Important Findings
- Diet and exercise interventions can lower BP in patients with resistant hypertension.
- A 4-month structured program of diet and exercise delivered in a cardiac rehabilitation setting results in significant reductions in clinic and ambulatory BP and improvement in selected cardiovascular disease biomarkers.
- C-LIFE participants exhibited lower clinic SBP (126.8 mm Hg) compared with SEPA (132.8 mm Hg; P=0.005).
- C-LIFE also showed lower clinic DBP (73.2 mm Hg) compared with SEPA (75.6 mm Hg; P=0.034).
- Postintervention 24-hour ambulatory BPs (SBP/DBP) were significantly lower for C-LIFE (126.4 mm Hg/67.2 mm Hg) compared with SEPA (133.2 mm Hg/70.8 mm Hg) (P=0.001 for SBP and P=0.002 for DBP).
- The study revealed a similar pattern in terms of weight changes and dietary composition.
- Examination of changes in aerobic fitness and functional capacity revealed greater improvements in peak VO₂ in the C-LIFE condition.
Limitations Noted in the Document
- The study was conducted at a single site, which may limit generalizability.
- The intervention’s effects on severe or refractory hypertension were not definitively established.
- The study was not designed to assess long-term effects or cardiovascular events.
- The study did not include urine levels of antihypertensive medications and their metabolites.
- The study included more Black participants in the SEPA group, which could have influenced results.
- The 4-month intervention might have been too short to produce clinically meaningful changes in certain CVD biomarkers.
Conclusion
The TRIUMPH trial successfully demonstrated that a structured lifestyle intervention, incorporating diet and exercise, can effectively lower blood pressure in patients with resistant hypertension. The key findings highlight the potential of lifestyle modifications, specifically a structured program of exercise and diet, to improve blood pressure control and cardiovascular health in a patient population where achieving these outcomes is particularly challenging. These results suggest that structured interventions in cardiac rehabilitation settings can be effective for patients with resistant hypertension. The study’s success underscores the importance of comprehensive, multidisciplinary approaches to healthcare, emphasizing the integration of lifestyle modifications within established care settings. The findings of the TRIUMPH study, in conjunction with existing evidence, advocate for a broader integration of lifestyle interventions into the treatment paradigm for hypertension, particularly for those with resistant forms of the condition. The study suggests the value of providing intensive, structured intervention to achieve these benefits. These findings emphasize the need for further research into the long-term impact of lifestyle interventions on cardiovascular outcomes and the cost-effectiveness of such programs. The study suggests that policymakers should consider RH as a new indication for cardiac rehabilitation with appropriate coverage by governmental agencies and private insurers.