Heart Inflammation and Mental Stress Study

Hypertension Clinical Trial

— HIMS  

Official title:

Heart Inflammation and Mental Stress Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695146
• Other study ID #: 20180631
• Secondary ID: K01HL139722-01
• Status: Completed
• Phase: N/A
• Start date: August 19, 2019
• Est. completion date: December 22, 2023

Study information

• Verified date: February 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: December 22, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Inflammation
• Stress, Psychological

Intervention

Behavioral:
• Paced 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.
• Active relaxation
Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability	Heart rate variability will be measured using a standard electrocardiogram to detect variability in R -to-R intervals.	Baseline, pre-intervention and up to 60 minutes post-intervention
Secondary	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.	Baseline, pre-intervention and up to 60 minutes post-intervention