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Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

Primary Purpose

Treatment-Resistant Hypertension

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Structured center-based lifestyle intervention

Standard education and physician advice

About this trial

This is an interventional treatment trial for Treatment-Resistant Hypertension

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Structured center-based lifestyle intervention

Standard education and physician advice

Arm Description

The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise.

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.

Outcomes

Primary Outcome Measures

Executive Function composite

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

Processing Speed composite

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

Memory composite

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

Secondary Outcome Measures

Brachial Artery Flow-Mediated Dilation

Prefrontal Cortex Tissue Oxygenation Index

Full Information

NCT ID

NCT03001427

First Posted

December 20, 2016

Last Updated

March 22, 2021

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT03001427

Brief Title

Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

Official Title

Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

February 27, 2020 (Actual)

Study Completion Date

December 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Treatment-Resistant Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

140 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Structured center-based lifestyle intervention

Arm Type

Experimental

Arm Description

The Structured center-based Lifestyle Intervention (C-LIFE) will include individualized plans for the DASH diet, weight management, and aerobic exercise.

Arm Title

Standard education and physician advice

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Structured center-based lifestyle intervention

Intervention Type

Behavioral

Intervention Name(s)

Standard education and physician advice

Primary Outcome Measure Information:

Title

Executive Function composite

Description

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

Time Frame