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Lifestyle Interventions in Treatment-Resistant Hypertension (TRIUMPH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342808
Recruitment Status : Active, not recruiting
First Posted : January 21, 2015
Last Update Posted : May 13, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE January 15, 2015
First Posted Date  ICMJE January 21, 2015
Last Update Posted Date May 13, 2020
Study Start Date  ICMJE June 2015
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
Change in clinic systolic blood pressure [ Time Frame: Baseline to immediate post-treatment (4 months) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2015)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lifestyle Interventions in Treatment-Resistant Hypertension
Official Title  ICMJE Treating Resistant Hypertension Using Lifestyle Modification to Promote Health
Brief Summary This study will examine the effects of lifestyle intervention on fitness, dietary habits, and body weight in patients with resistant hypertension (RH). Patients will be randomized to either a 4-month adjunctive lifestyle intervention designed to lower BP that will be delivered in a center-based CR program (C-LIFE), or to standardized education and physician advice (SEPA) designed to promote the same healthy behaviors and reflecting the current highest possible standard of care for promoting a healthy lifestyle in RH.
Detailed Description

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Treatment-Resistant Hypertension
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Structured center-based lifestyle intervention
  • 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.
    Intervention: Behavioral: Standard education and physician advice
Publications * Blumenthal JA, Sherwood A, Smith PJ, Mabe S, Watkins L, Lin PH, Craighead LW, Babyak M, Tyson C, Young K, Ashworth M, Kraus W, Liao L, Hinderliter A. Lifestyle modification for resistant hypertension: The TRIUMPH randomized clinical trial. Am Heart J. 2015 Nov;170(5):986-994.e5. doi: 10.1016/j.ahj.2015.08.006. Epub 2015 Aug 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 12, 2020)
140
Original Estimated Enrollment  ICMJE
 (submitted: January 20, 2015)
150
Estimated Study Completion Date  ICMJE November 2020
Actual Primary Completion Date May 8, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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)
  • Sedentary
  • Willing to be randomized to one of the 2 treatment groups and able to fully participate in intervention
  • Informed consent

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342808
Other Study ID Numbers  ICMJE Pro00055703
1R01HL122836-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: James A. Blumenthal, PhD Duke University
Principal Investigator: Andrew Sherwood, PhD Duke University
PRS Account Duke University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP