Heart Inflammation and Mental Stress Study (HIMS)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Paced breathing; Behavioral: Active relaxation

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paced breathing; Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. Individuals in this arm will engage in a paced breathing. Initial respiratory rate will be measured with a transducer. Participants will be connected to a paced breathing device (RESPERATE) that will gradually reduce the pace of audio tones presented to those individuals from spontaneous breathing rate down to 6 - 8 breaths per minute.	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 Comparator: Relaxing music; Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes. Individuals will be provided with an audio device that plays soothing/relaxing music at a similar range (beats per minute) of the auditory signal presented during the experimental condition. Subjects will not be instructed how to breathe in this arm.	Behavioral: Active relaxation; Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
No Intervention: No intervention; Individuals will be asked to sit in a quiet room while sensors collect their heart rate, respiratory rate and blood pressure for approximately 45 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Roger C McIntosh, Ph.D., University of Miami, College of Arts and Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2019
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 22, 2023

Study Registration Dates

• First Submitted: September 28, 2018
• First Submitted That Met QC Criteria: October 2, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: HIV; High blood pressure
• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Inflammation; Stress, Psychological
• Other Study ID Numbers: 20180631; K01HL139722-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No