Heart Inflammation and Mental Stress Study (HIMS)

University of Miami

Status: Completed

Conditions: Hypertension

Treatments: Behavioral: Active relaxation; Behavioral: Paced breathing

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03695146

20180631

K01HL139722-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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52 participants in 3 patient groups

Paced breathing

Experimental group

Description:

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.

Treatment:

Behavioral: Paced breathing

Relaxing music

Active Comparator group

Description:

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.

Treatment:

Behavioral: Active relaxation

No intervention

No Intervention group

Description:

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.