Lifestyle Interventions in Treatment-Resistant Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

NCT03001427

Treatment-Resistant Hypertension

COMPLETED NA

Interventions to Improve Hypertension Control and Reduce Cardiovascular Disease Risk

NCT00201136

Hypertension

COMPLETED PHASE2

Hypertension in Primary Health Care: Lifestyle Change and Blood Pressure Goals

NCT01085890

Blood Pressure Life Style

COMPLETED NA

Lowering Blood Pressure by Changing Lifestyle

NCT04505150

High Blood Pressure

UNKNOWN NA

Effect of Lifestyle Intervention Among Patients With Hypertension or High-normal Blood Pressure

NCT05528068

Hypertension High-normal Blood Pressure

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Treatment-Resistant Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Structured center-based lifestyle intervention

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Standard education and physician advice

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No