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Heart Inflammation and Mental Stress Study

Heart Inflammation and Mental Stress Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03695146
Acronym
HIMS
Enrollment
52
Registered
2018-10-03
Start date
2019-08-19
Completion date
2023-12-22
Last updated
2024-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

High blood pressure, HIV

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.

Interventions

BEHAVIORALPaced breathing

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.

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

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in heart rate variabilityBaseline, pre-intervention and up to 60 minutes post-interventionHeart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.

Secondary

MeasureTime frameDescription
Change in cytokine expression in peripheral blood mononuclear cellsBaseline, pre-intervention and up to 60 minutes post-interventionPeripheral 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026