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Clinical Trials/NCT03695146
NCT03695146
Completed
Not Applicable

Heart Inflammation and Mental Stress Study

University of Miami1 site in 1 country52 target enrollmentAugust 19, 2019
ConditionsHypertension

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hypertension
Sponsor
University of Miami
Enrollment
52
Locations
1
Primary Endpoint
Change in heart rate variability
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 19, 2019
End Date
December 22, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Roger McIntosh

Assistant Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in heart rate variability

Time Frame: 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 Outcomes

  • Change in cytokine expression in peripheral blood mononuclear cells(Baseline, pre-intervention and up to 60 minutes post-intervention)

Study Sites (1)

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