Lifestyle Interventions in Treatment-Resistant Hypertension (TRIUMPH)
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|ClinicalTrials.gov Identifier: NCT02342808|
Recruitment Status : Completed
First Posted : January 21, 2015
Last Update Posted : February 4, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Treatment-Resistant Hypertension||Behavioral: Structured center-based lifestyle intervention Behavioral: Standard education and physician advice||Not Applicable|
The term resistant hypertension (RH) is defined as clinic blood pressure (BP) that remains above goal (e.g., systolic blood pressure [SBP]>140 mm Hg and/or diastolic blood pressure [DBP]>90 mm Hg), despite adherence to a regimen of 3 or more antihypertensive medications of different classes, one of which is a diuretic.
With the growing prevalence of hypertension (HTN) in this country, RH is a major public health concern, affecting more than 7.5 million Americans. Patients with RH are 50% more likely to experience a CVD event, including stroke, kidney failure, myocardial infarction, and death, compared to patients with controlled BP. There is an urgent need for developing RH management strategies to lower BP as well as to reduce the high risk of CVD-related events. Lifestyle modifications, including exercise training and dietary modification, are of proven efficacy in lowering BP in unmedicated patients with HTN and are often recommended as the first step for treating high BP. The Dietary Approaches to Stop Hypertension (DASH) diet has been shown to lower BP in HTN patients who are not treated with drugs. Moreover, when the DASH diet is combined with exercise and caloric restriction, even greater, and quite marked, BP reductions can be achieved. However, the efficacy of these lifestyle modifications in HTN patients who are refractory to medical therapy is unknown. This application aims to build upon evidence supporting the value of lifestyle modifications in unmedicated patients with HTN by proposing a randomized clinical trial (RCT) that will evaluate whether an intensive, medically-supervised lifestyle intervention can successfully lower BP in medicated patients with RH.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Treating Resistant Hypertension Using Lifestyle Modification to Promote Health|
|Study Start Date :||June 2015|
|Actual Primary Completion Date :||May 8, 2020|
|Actual Study Completion Date :||December 14, 2020|
Experimental: Structured center-based lifestyle intervention
The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise.
Behavioral: Structured center-based lifestyle intervention
Participants will meet with interventionists weekly for 16 weeks and receive instruction on the DASH diet with caloric and sodium restriction and will exercise three times per week at one of the designated CR facilities, under the supervision of medically trained staff, 3 times per week for 16 weeks.
Experimental: Standard education and physician advice
The Medical Management with Standardized Education and Physician Advice (SEPA) will consist of encouragement to achieve an ideal body weight and engage in exercise as part of routine counseling in primary care, but no special program will be delivered to enhance the participants' ability to comply with these recommendations.
Behavioral: Standard education and physician advice
Participants will receive routine medical care provided by the participants' primary care physician(s) supplemented by an educational session on hypertension management. Participants will receive a dietary consultation from the study nutritionist and an individualized exercise prescription from an exercise physiologist, but not participate in a structured program. Participants will be free to engage in diet and exercise for the 16-week intervention.
- Change in clinic systolic blood pressure [ Time Frame: Baseline to immediate post-treatment (4 months) ]
- Change in 24-hour ambulatory systolic blood pressure [ Time Frame: Baseline to immediate post-treatment (4 months) ]
- Weight [ Time Frame: Immediate post-treatment (4 months) ]
- Aerobic capacity (Measured via an exercise treadmill stress test with VO2 collection) [ Time Frame: Immediate post-treatment (4 months) ]Measured via an exercise treadmill stress test with VO2 collection
- DASH Diet adherence (Measured via food diary recall) [ Time Frame: Immediate post-treatment (4 months) ]Measured via food diary recall
- Change in Cardiovascular Disease (CVD) biomarker composite score [ Time Frame: Baseline to immediate post-treatment (4 months) ]Biomarkers of interest include: left ventricular hypertrophy, arterial stiffness, baroreceptor reflex sensitivity, insulin resistance, lipid profiles, sympathetic nervous system (SNS) activity, and inflammatory markers
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|Ages Eligible for Study:||35 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Documented resistant hypertension (RH). In the absence of a specific RH diagnosis, individuals being treated for two or more weeks with 3 antihypertensive medications of different classes, including a diuretic if tolerated, with clinic SBP ≥ 130 mm Hg or DBP ≥ 80 mm Hg, will be eligible. Individuals being treated with 4 or more antihypertensive medications, including a diuretic if tolerated, with SBP ≥ 120 or DBP ≥ 80 mm Hg will also be eligible.
- Adherent to prescribed medications
- Overweight (BMI ≥ 25 kg/m2)
- Willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
- Informed consent
- Secondary HTN, non-adherence to anti-HTN medications
- Severe CKD (eGFR <40 ml/min/1.73m2)
- Severe ischemic heart disease (CCS Class 3 or 4 angina or evidence of ischemia at <85% heart rate reserve on treadmill testing)
- Severe heart failure (NYHA association Class 3 or 4), high grade arrhythmias, severe valvular heart disease
- Severe asthma or chronic obstructive lung disease
- Diabetes requiring insulin
- Musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training
- Major psychiatric disorder, a history of drug abuse, alcohol consumption >14 drinks/week
- Life-limiting comorbid medical condition such as cancer
- Prior gastric bypass surgery
- Currently pregnant
- Cognitively impaired
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342808
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||James A. Blumenthal, PhD||Duke University|
|Principal Investigator:||Andrew Sherwood, PhD||Duke University|
|Responsible Party:||Duke University|
|Other Study ID Numbers:||
1R01HL122836-01A1 ( U.S. NIH Grant/Contract )
|First Posted:||January 21, 2015 Key Record Dates|
|Last Update Posted:||February 4, 2021|
|Last Verified:||February 2021|