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TRIUMPH

Lifestyle Modification for Resistant Hypertension: The TRIUMPH Randomized Clinical Trial

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Year of Publication: 2015

Authors: James A. Blumenthal, Andrew Sherwood, Patrick J. Smith, ..., Alan Hinderliter

Journal: American Heart Journal

Citation: Am Heart J. 2015 November; 170(5): 986–994.e5

Link: https://doi.org/10.1016/j.ahj.2015.08.006

PDF: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4636732/

Clinical Question

Can an intensive, center-based lifestyle intervention achieve clinically significant blood pressure lowering in patients with resistant hypertension compared to standardized education and physician advice?

Study Overview

Objective

To evaluate the efficacy of a center-based lifestyle intervention consisting of exercise training, reduced sodium and calorie DASH eating plan, and weight management compared to standardized education and physician advice in treating patients with resistant hypertension

Study Summary

This is a study protocol for the TRIUMPH trial, not results
150 patients with resistant hypertension will be randomized 2:1 to intensive lifestyle intervention vs. standardized education
Primary endpoint is clinic blood pressure at 4 months with 1-year follow-up

Intervention

Center-based Lifestyle Intervention (C-LIFE): 4-month supervised program with DASH diet, exercise training, weight management, and behavioral counseling vs. Standardized Education and Physician Advice (SEPA)

Patients per Arm

100 intervention, 50 control

Bottom Line

This is a study protocol paper describing the design of the TRIUMPH trial - no results are reported

        Major Points
        Single-site randomized controlled trial of 150 patients with resistant hypertension
2:1 randomization to intensive lifestyle intervention vs. standardized education
Primary endpoint is clinic systolic blood pressure at 4 months
Intervention includes DASH diet, exercise training, weight management, and behavioral counseling
Follow-up extends to 1 year post-randomization
Power calculation shows 80% power to detect 5.4 mmHg difference in clinic SBP

      

Design

Study Type: Randomized controlled trial

Randomization: 1

Blinding: Not specified in protocol

Enrollment Period: Not specified

Follow-up Duration: 1 year

Centers: 1

Countries: United States

Sample Size: 150

Analysis: Intent-to-treat using multiple imputation, ANCOVA with covariates including ethnicity, gender, age, diabetes/CKD, baseline medication adherence, pre-treatment SBP

Inclusion Criteria

Documented resistant hypertension within 6 months
SBP ≥140 mmHg or DBP ≥90 mmHg on ≥3 antihypertensive medications including diuretic for ≥2 weeks
OR SBP ≥130 or DBP ≥85 mmHg on ≥4 antihypertensive medications including diuretic
BMI 25-39.9 kg/m²
Sedentary lifestyle (exercise <30 min/week)
Age 35-80 years
Willingness to be randomized

Exclusion Criteria

Secondary hypertension
Severe chronic kidney disease (eGFR <45 ml/min/1.73m²)
Moderate-severe ischemic heart disease
Severe heart failure (NYHA Class 3-4)
High grade arrhythmias
Severe valvular heart disease
Severe asthma or COPD
Diabetes requiring insulin
Musculoskeletal or neurologic problems precluding exercise
Current major psychiatric disorder or active drug abuse
Alcohol consumption >14 drinks/week
Prior gastric bypass surgery
Life-limiting comorbid condition
Pseudoresistant hypertension due to non-adherence or white coat effect

Baseline Characteristics

Characteristic	Control	Active
Note	This is a protocol paper - baseline characteristics will be reported in results publication	This is a protocol paper - baseline characteristics will be reported in results publication

Arms

Field	Control	Center-based Lifestyle Intervention (C-LIFE)
Intervention	Routine medical care with educational session on hypertension management, dietary consultation, and individualized exercise prescription delivered by health educator	4-month supervised program including: DASH diet with sodium restriction (2300mg/day), behavioral weight management (16 weekly sessions), supervised exercise 3x/week at 70-85% heart rate reserve, and maintenance planning
Duration	Single session	4 months

Outcomes

Outcome	Type	Control	Intervention
Clinic systolic blood pressure at 4 months	Primary	Protocol paper - results pending	Protocol paper - results pending
Ambulatory daytime systolic blood pressure	Secondary	Protocol paper - results pending	Protocol paper - results pending
Left ventricular mass and geometry	Secondary	Protocol paper - results pending	Protocol paper - results pending
Arterial stiffness	Secondary	Protocol paper - results pending	Protocol paper - results pending
Quality of life measures	Secondary	Protocol paper - results pending	Protocol paper - results pending
Note	Adverse		Protocol paper - adverse events will be reported in results publication

Subgroup Analysis

Planned moderator analyses will examine race, age, gender, presence of kidney disease or diabetes, baroreflex sensitivity, and baseline BMI and physical activity levels

Criticisms

This is a protocol paper only - no results or outcomes reported
Single-center study may limit generalizability
Unblinded intervention due to nature of lifestyle modification
2:1 randomization may introduce imbalance
Adherence to lifestyle interventions may be challenging to maintain long-term

Funding

National Heart, Lung, and Blood Institute grant HL122836

Based on: TRIUMPH (American Heart Journal, 2015)