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Lifestyle Interventions in Treatment-Resistant Hypertension (TRIUMPH)

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ClinicalTrials.gov Identifier: NCT02342808
Recruitment Status : Recruiting
First Posted : January 21, 2015
Last Update Posted : June 5, 2018
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Treatment-Resistant Hypertension Behavioral: Structured center-based lifestyle intervention Behavioral: Standard education and physician advice Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Treating Resistant Hypertension Using Lifestyle Modification to Promote Health
Study Start Date : June 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Change in clinic systolic blood pressure [ Time Frame: Baseline to immediate post-treatment (4 months) ]

Secondary Outcome Measures :
  1. Change in 24-hour ambulatory systolic blood pressure [ Time Frame: Baseline to immediate post-treatment (4 months) ]
  2. Weight [ Time Frame: Immediate post-treatment (4 months) ]
  3. 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

  4. DASH Diet adherence (Measured via food diary recall) [ Time Frame: Immediate post-treatment (4 months) ]
    Measured via food diary recall

  5. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: James A. Blumenthal, PhD 919-684-3828 blume003@mc.duke.edu
Contact: Stephanie K. Mabe, MS 919-668-3555 stephanie.mabe@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: James A. Blumenthal, Ph.D.    919-684-3828    blume003@mc.duke.edu   
Principal Investigator: James A. Blumenthal, Ph.D.         
Principal Investigator: Andrew Sherwood, Ph.D.         
Sponsors and Collaborators
Duke University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: James A. Blumenthal, PhD Duke University
Principal Investigator: Andrew Sherwood, PhD Duke University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02342808     History of Changes
Other Study ID Numbers: Pro00055703
1R01HL122836-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2015    Key Record Dates
Last Update Posted: June 5, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases