Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

NCT03001427 | Completed DMC

• 1 other identifier: Pro00055703_1
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Executive Function composite

  Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index

  Baseline to immediate post-treatment (4 months)

• Processing Speed composite

  Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2\&7 Test

  Baseline to immediate post-treatment (4 months)

• Memory composite

  CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa

  Baseline to immediate post-treatment (4 months)

Secondary Outcomes (2)

• Brachial Artery Flow-Mediated Dilation

  Baseline to immediate post-treatment (4 months)

• Prefrontal Cortex Tissue Oxygenation Index

  Baseline to immediate post-treatment (4 months)

Other Outcomes (3)

• Executive Function composite

  Baseline to follow-up (1 year)

• Processing Speed composite

  Baseline to follow-up (1 year)

• Memory composite

  Baseline to follow-up (1 year)

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

Structured center-based lifestyle intervention

Standard education and physician advice BEHAVIORAL

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

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• 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 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: December 23, 2016
• Study Start: January 1, 2016
• Primary Completion: February 27, 2020
• Study Completion: December 14, 2020
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)