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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

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?

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

Arms

FieldControlCenter-based Lifestyle Intervention (C-LIFE)
InterventionRoutine medical care with educational session on hypertension management, dietary consultation, and individualized exercise prescription delivered by health educator4-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
DurationSingle session4 months

Outcomes

OutcomeTypeControlInterventionHR / OR / RRP-value
Clinic systolic blood pressure at 4 monthsPrimaryProtocol paper - results pendingProtocol paper - results pending
Ambulatory daytime systolic blood pressureSecondaryProtocol paper - results pendingProtocol paper - results pending
Left ventricular mass and geometrySecondaryProtocol paper - results pendingProtocol paper - results pending
Arterial stiffnessSecondaryProtocol paper - results pendingProtocol paper - results pending
Quality of life measuresSecondaryProtocol paper - results pendingProtocol paper - results pending
Protocol paper - adverse events will be reported in results publicationAdverse

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)

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

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

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