NCT03001427

Neurocognition, Lifestyle Modification, and Treatment Resistant Hypertension

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment-Resistant Hypertension

Interventions

Type	Name	Description
BEHAVIORAL	Structured center-based lifestyle intervention
BEHAVIORAL	Standard education and physician advice

Timeline

• Start date: 2016-01-01
• Primary completion: 2020-02-27
• Completion: 2020-12-14
• First posted: 2016-12-23
• Last updated: 2021-03-23

Locations

1 site across 1 country: United States