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Completed

NCT Number: NCT03001427

Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

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.

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Key information

Conditions

Treatment-Resistant Hypertension

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured center-based lifestyle intervention

Behavioral

Standard education and physician advice

Behavioral

Primary outcomes

  1. 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

  2. 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

  3. Memory composite

    Time frame: Baseline to immediate post-treatment (4 months)

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

Secondary outcomes

  1. Brachial Artery Flow-Mediated Dilation

    Time frame: Baseline to immediate post-treatment (4 months)

  2. Prefrontal Cortex Tissue Oxygenation Index

    Time frame: Baseline to immediate post-treatment (4 months)

Other outcomes

  1. Executive Function composite

    Time frame: Baseline to follow-up (1 year)

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

  2. Processing Speed composite

    Time frame: Baseline to follow-up (1 year)

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

  3. Memory composite

    Time frame: Baseline to follow-up (1 year)

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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 23, 2016
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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