Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

NCT ID: NCT03001427

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-12-14

Brief Summary

This application proposes to extend an ongoing NHLBI clinical trial (NCT02342808) examining the efficacy of a lifestyle intervention combining the Dietary Approaches to Stop Hypertension (DASH) diet with caloric restriction and aerobic exercise to lower and control BP in individuals with RH. In the parent trial, participants with RH will be randomized to either: (1) a 4-month adjunctive lifestyle intervention designed to lower BP through exercise and diet (C-LIFE), or; (2) a standardized education and physician advice (SEPA) control condition.

The current protocol will collect additional assessments of neurocognition (executive function, processing speed, and memory), endothelial function (brachial artery flow-mediated dilation), and cerebrovascular reserve (a measure of prefrontal cortex tissue oxygenation) in 120 participants at baseline, following completion of the 4-month intervention, and again after one year, in order to examine neurocognitive improvements and their potential mediators.

Conditions

Treatment-Resistant Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

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

Interventions

Structured center-based lifestyle intervention

Intervention Type: BEHAVIORAL

Standard education and physician advice

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26542509 (View on PubMed)

Other Identifiers

Pro00055703_1

Identifier Type: -

Identifier Source: org_study_id