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Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

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ClinicalTrials.gov Identifier: NCT03001427
Recruitment Status : Recruiting
First Posted : December 23, 2016
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.


Condition or disease Intervention/treatment Phase
Treatment-Resistant Hypertension Behavioral: Structured center-based lifestyle intervention Behavioral: Standard education and physician advice Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Arm Intervention/treatment
Experimental: 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.
Behavioral: Structured center-based lifestyle intervention
Experimental: 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.
Behavioral: Standard education and physician advice



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03001427


Contacts
Contact: Patrick J Smith, PhD, MPH 919-681-3006 patrick.j.smith@dm.duke.edu
Contact: Stephanie K Mabe, MS 919-668-3555 stephanie.mabe@duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University

Publications:
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03001427     History of Changes
Other Study ID Numbers: Pro00055703_1
First Posted: December 23, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases