Hypertension Clinical Trial
— HIMSOfficial title:
Heart Inflammation and Mental Stress Study
Verified date | February 2024 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
University of Miami | National Heart, Lung, and Blood Institute (NHLBI) |
United States,
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 |
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