Heart Inflammation and Mental Stress Study

Not Applicable

Completed

• Conditions: Hypertension

• Registration Number: NCT03695146
• Lead Sponsor: University of Miami

Brief Summary

The aim of the study is to investigate the neural underpinnings of cardiovascular reactivity to mental stress as a function of HIV and hypertensive risk.

Detailed Description

The main objectives of the study are to assess (1) patterns of brain activity/connectivity that confers greater cardio-autonomic/emotion regulation, (e.g., heart rate variability, blood pressure reactivity, inflammatory-immune activation, etc.), during rest, mental stress, and anger-related distress, (2) whether changes in breathing pace mitigate task-based effects on cardio-autonomic-immune regulation, and (3) whether these patterns vary as a function of HIV or pre-hypertensive (HTN) status-related changes to the brain structures underlying cardioautonomic and emotion regulation.

Study Timeline

• Study First Submitted: 2018-09-28
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• Study Start: 2019-08-19
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-22
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in heart rate variability	Baseline, pre-intervention and up to 60 minutes post-intervention	Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.

Secondary Outcome Measures

Name	Time	Method
Change in cytokine expression in peripheral blood mononuclear cells	Baseline, pre-intervention and up to 60 minutes post-intervention	Peripheral blood will be drawn and mononuclear cells isolated and incubated with lipopolysaccharide to induce inflammatory cytokine expression. The change in cytokine expression will be quantified as a function of time.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States