Lifestyle Interventions in Treatment-Resistant Hypertension

NCT02342808 | Completed DMC

• 2 other identifiers: Pro000557031R01HL122836-01A1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Treatment-Resistant Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in clinic systolic blood pressure

  Baseline to immediate post-treatment (4 months)

Secondary Outcomes (5)

• Change in 24-hour ambulatory systolic blood pressure

  Baseline to immediate post-treatment (4 months)

• Weight

  Immediate post-treatment (4 months)

• Aerobic capacity (Measured via an exercise treadmill stress test with VO2 collection)

  Immediate post-treatment (4 months)

• DASH Diet adherence (Measured via food diary recall)

  Immediate post-treatment (4 months)

• Change in Cardiovascular Disease (CVD) biomarker composite score

  Baseline to immediate post-treatment (4 months)

Study Arms (2)

Structured center-based lifestyle intervention

EXPERIMENTAL

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

Standard education and physician advice

EXPERIMENTAL

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

Interventions

Structured center-based lifestyle intervention BEHAVIORAL

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.

Structured center-based lifestyle intervention

Standard education and physician advice BEHAVIORAL

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.

Standard education and physician advice

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (4)

• Blumenthal JA, Smith PJ, Mabe S, Hinderliter A, Craighead L, Watkins LL, Ingle K, Tyson CC, Lin PH, Kraus WE, Liao L, Sherwood A. Effects of Lifestyle Modification on Psychosocial Function in Patients With Resistant Hypertension: SECONDARY OUTCOMES FROM THE TRIUMPH RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2024 Jan 1;44(1):64-70. doi: 10.1097/HCR.0000000000000801. Epub 2023 May 24.

  PMID: 37220236 DERIVED

• Blumenthal JA, Hinderliter AL, Smith PJ, Mabe S, Watkins LL, Craighead L, Ingle K, Tyson C, Lin PH, Kraus WE, Liao L, Sherwood A. Effects of Lifestyle Modification on Patients With Resistant Hypertension: Results of the TRIUMPH Randomized Clinical Trial. Circulation. 2021 Oct 12;144(15):1212-1226. doi: 10.1161/CIRCULATIONAHA.121.055329. Epub 2021 Sep 27.

  PMID: 34565172 DERIVED

• Smith PJ, Mabe SM, Sherwood A, Doraiswamy PM, Welsh-Bohmer KA, Burke JR, Kraus WE, Lin PH, Browndyke JN, Babyak MA, Hinderliter AL, Blumenthal JA. Metabolic and Neurocognitive Changes Following Lifestyle Modification: Examination of Biomarkers from the ENLIGHTEN Randomized Clinical Trial. J Alzheimers Dis. 2020;77(4):1793-1803. doi: 10.3233/JAD-200374.

  PMID: 32925039 DERIVED

• 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.

  PMID: 26542509 DERIVED

Study Officials

• James A. Blumenthal, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

• Andrew Sherwood, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 21, 2015
• Study Start: June 1, 2015
• Primary Completion: May 8, 2020
• Study Completion: December 14, 2020
• Last Updated: February 4, 2021

Record last verified: 2021-02

Locations

US (1)