Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 35 - Any |
| Updated: | 1/6/2019 |
| Start Date: | January 2016 |
| End Date: | January 2021 |
| Contact: | Patrick J Smith, PhD, MPH |
| Email: | patrick.j.smith@dm.duke.edu |
| Phone: | 919-681-3006 |
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.
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.
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
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