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OpenTrials
Completed

NCT Number: NCT03695146

Heart Inflammation and Mental Stress Study

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pre-hypertension screening.
  • HIV-antibody testing.

Exclusion criteria

  • current use of anti-lipid, antihypertensive, or heart rate altering medications;
  • current or lifetime history of cardiovascular disease diagnosis or treatment including pulmonary stenosis, heart valve abnormalities and hypertension;
  • current or lifetime diagnoses of cancer, kidney/liver disease, hypertension, Type 1 or Type 2 diabetes;
  • history of trauma, cerebral infarction or hemorrhage;
  • current diagnosis and/or treatment for hypertension;
  • severe cognitive impairment;
  • current treatment or diagnosis of psychiatric illness;
  • metal implants or debris within the body; or pregnancy;
  • body mass index > 35;
  • use of hormone replacement therapy; and current smoker.

Treatment and study plan

Paced breathing

Behavioral

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 relaxation

Behavioral

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

Primary outcomes

  1. 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

  1. Change in cytokine expression in peripheral blood mononuclear cells

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: HIMS

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Oct 3, 2018
Registry last updated
Feb 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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