Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Duke University
- Enrollment
- 140
- Locations
- 2
- Primary Endpoint
- Executive Function composite
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 35 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Executive Function composite
Time Frame: Baseline to immediate post-treatment (4 months)
Trail Making Test Part B, Stroop Color-Word Section, Animal Naming, COWA, CVLT-II Discrimination Index
Memory composite
Time Frame: Baseline to immediate post-treatment (4 months)
CVLT-II Learning, CVLT-II Free Recall, RCFT Recall, Digit Spa
Processing Speed composite
Time Frame: Baseline to immediate post-treatment (4 months)
Trail Making Test Part A, Stroop Word Section, Stroop Color Section, Digit Symbol, Ruff 2\&7 Test
Secondary Outcomes
- Brachial Artery Flow-Mediated Dilation(Baseline to immediate post-treatment (4 months))
- Prefrontal Cortex Tissue Oxygenation Index(Baseline to immediate post-treatment (4 months))