Heart Inflammation and Mental Stress Study

University of Miami52 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Hypertension

Interventions

Paced breathingBEHAVIORAL

Individuals will be fitted with a respiratory transducer and receive auditory tones with which to pace their rate of inspiration and expiration in the experimental group.

Active relaxationBEHAVIORAL

Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. pre-hypertension screening. 2. HIV-antibody testing. Exclusion criteria: 1. current use of anti-lipid, antihypertensive, or heart rate altering medications; 2. current or lifetime history of cardiovascular disease diagnosis or treatment including pulmonary stenosis, heart valve abnormalities and hypertension; 3. current or lifetime diagnoses of cancer, kidney/liver disease, hypertension, Type 1 or Type 2 diabetes; 4. history of trauma, cerebral infarction or hemorrhage; 5. current diagnosis and/or treatment for hypertension; 6. severe cognitive impairment; 7. current treatment or diagnosis of psychiatric illness; 8. metal implants or debris within the body; or pregnancy; 9. body mass index \> 35; 10. use of hormone replacement therapy; and current smoker.

Locations (1)

University of Miami

Miami, Florida, United States

Outcomes

Primary Outcomes

Change in heart rate variability

Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.

Time frame: Baseline, pre-intervention and up to 60 minutes post-intervention

Secondary Outcomes

Change in cytokine expression in peripheral blood mononuclear cells

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.

Time frame: Baseline, pre-intervention and up to 60 minutes post-intervention

Data from ClinicalTrials.gov

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