Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2026-01-04 @ 10:10 PM
Study NCT ID:
NCT02401269
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2015-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiovascular Risk in HIV Patients on Antiretroviral Therapy Therapy: The MHEART Study
Sponsor:
University of Pittsburgh
Organization:
Study Overview
Official Title:
Cardiovascular Risk in HIV Patients on Antiretroviral Therapy Therapy: The MHEART Study
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MHEART
Brief Summary:
CVD accounts for 15% of all deaths in Malawi. Both HIV and ART are risk factors for CVD through direct toxic and inflammatory cardiovascular effects. (44,45). At the moment, one out of every 10 Malawian is HIV positive and roughly 8 out of 10 of those infected are now on ART (2). Therefore, HIV and ART may be contributing to the burden of CVD in Malawi. Currently, there are only a few studies assessing CVD risk in the HIV patient population on ART. In Malawi, no such studies exist. Therefore, the investigators propose a novel study assessing baseline cardiovascular disease risk using two novel ultrasound technologies in HIV patients on ART. Cardiovascular disease risk will be assessed using surrogate cardiovascular markers of disease. These surrogates include markers of endothelial function and cardiovascular modulating inflammatory biomarkers. The inflammatory biomarkers measured will be TNF-alpha, IL-6, and CRP. Aspirin, by way of its antiplatelet and anti-inflammatory effect has been demonstrated to inhibit atherosclerosis by way of decreasing TNF-alpha, IL-6, CRP and improving endothelial function. Therefore a second aim of the study will be to demonstrate that aspirin improves surrogate markers of atherosclerosis.
Detailed Description:
To address our objectives we have designed a six-month prospective randomized controlled study (RCT) investigating cardiovascular disease risk in HIV patients on ART with the implementation of an aspirin versus placebo strategy to investigate whether this risk can be modified. As nearly all HIV patients are anticipated to be on ART in the upcoming decade, we have decided to open this study to only virally suppressed HIV on ART. A total of 100 virally suppressed HIV positive Malawians on ART will be enrolled in this study. Initial screening will occur in the patient population identified as being HIV positive with viral load suppression on ART in the last 3 months. The initial screening will provide cross-sectional information on baseline demographic, clinical, and laboratory characteristics of virally suppressed HIV patients on ART and will assess baseline cardiovascular risk using laboratory biomarker data and endothelial function as surrogate markers (see section under procedures). Ability of distal arteries to dilate under stress will be measured using novel ultrasound technologies applicable to the limited resource healthcare settings in Malawi. After initial screening, eligibility into the study will be determined and selected participants will be randomized into one of two arms:
1. Oral aspirin 325mg daily
2. Oral placebo daily.
This longitudinal RCT will reassess cardiovascular risk at the one-month, 3-month, and six-month mark using the same CVD surrogate measurements of atherosclerosis performed during the initial screening.
Procedures assessing surrogate CVD markers for atherosclerosis:
1. Laboratory analysis (Venipuncture): Inflammatory biomarkers
• C-Reactive Protein (CRP), Interleukin-6, Tumor Necrosis Factor- alpha
2. Endo-PAT analysis
3. Brachial Flow Mediated dilation
4. Carotid Intima-Media Thickness
1. Oral aspirin 325mg daily
2. Oral placebo daily.
This longitudinal RCT will reassess cardiovascular risk at the one-month, 3-month, and six-month mark using the same CVD surrogate measurements of atherosclerosis performed during the initial screening.
Procedures assessing surrogate CVD markers for atherosclerosis:
1. Laboratory analysis (Venipuncture): Inflammatory biomarkers
• C-Reactive Protein (CRP), Interleukin-6, Tumor Necrosis Factor- alpha
2. Endo-PAT analysis
3. Brachial Flow Mediated dilation
4. Carotid Intima-Media Thickness
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: