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Heart Inflammation and Mental Stress Study (HIMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03695146
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : September 28, 2022
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Roger McIntosh, University of Miami

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Paced breathing Behavioral: Active relaxation Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Heart Inflammation and Mental Stress Study
Actual Study Start Date : August 19, 2019
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stress

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695146


Contacts
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Contact: Roger C McIntosh, Ph.D. 305-243-2047 r.mcintosh@miami.edu
Contact: Katie Dillon, M.S. 305-243-1266 kxd@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Roger C McIntosh, PhD    305-243-2047 ext 3    r.mcintosh@miami.edu   
Principal Investigator: Roger C McIntosh, PhD         
Sponsors and Collaborators
University of Miami
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Roger C McIntosh, Ph.D. University of Miami, College of Arts and Sciences
More Information
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Responsible Party: Roger McIntosh, Assistant Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03695146    
Other Study ID Numbers: 20180631
K01HL139722-01 ( U.S. NIH Grant/Contract )
First Posted: October 3, 2018    Key Record Dates
Last Update Posted: September 28, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Roger McIntosh, University of Miami:
High blood pressure
HIV
Additional relevant MeSH terms:
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Inflammation
Stress, Psychological
Pathologic Processes
Behavioral Symptoms