Mechanisms of Diastolic Dysfunction Among Persons With HIV Compared With Non-HIV Control Subjects
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology, Cardiology, HIV / AIDS |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 1/23/2019 |
| Start Date: | August 2016 |
| End Date: | July 2019 |
| Contact: | Tomas Neilan, MD |
| Email: | tneilan@mgh.harvard.edu |
| Phone: | 617-724-5351 |
In this study, investigators plan to test two potential mechanisms contributing to diastolic
dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism
is that heightened systemic immune activation/inflammation in HIV contributes to myocardial
inflammation, which in turn promotes myocardial fibrosis. The second mechanism is that
ectopic fat deposition (increased visceral adiposity) in HIV relates to increased
intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV
positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for
evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid
content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and
markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS
outcomes.
dysfunction among asymptomatic persons with HIV who are on cART. The first proposed mechanism
is that heightened systemic immune activation/inflammation in HIV contributes to myocardial
inflammation, which in turn promotes myocardial fibrosis. The second mechanism is that
ectopic fat deposition (increased visceral adiposity) in HIV relates to increased
intramyocardial lipid content, which in turn contributes to diastolic dysfunction. Both HIV
positive and HIV-negative participants will undergo cardiac MRI/ MRS imaging studies for
evaluation of myocardial fibrosis, myocardial inflammation, and intramyocardial lipid
content. Traditional markers of CVD risk, inflammatory markers/immune, hormonal markers, and
markers of myocardial stretch/injury will be assessed in relation to cardiac MRI/MRS
outcomes.
HIV positive subjects
Inclusion Criteria:
- age ≥40 and ≤75 years
- documented HIV infection
- participant report that combination antiretroviral therapy (cART) (any regimen) has
been taken stably without > 4 week interruption for at least 180 days prior to study
entry (report of switching regimens in that time frame is permissible)
Exclusion Criteria:
- CD4 < 100 cell/mm3
- current active AIDS-defining illness
- current active or recent (not fully resolved within 30 days prior to study entry)
systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human
papillomavirus [HPV], or HCV)
- current active cancer
- clinical ASCVD, as defined by 2013 ACC/AHA guidelines (including previous diagnosis of
AMI, ACS, stable or unstable angina, coronary or other arterial revascularization,
stroke, TIA, PAD), by subject report
- clinical diagnosis of HFpEF or HFrEF, by subject report
- diagnosed DM on antihyperglycemic medication
- current, active use of immune suppressant medication including oral or intravenous
corticosteroid or injectable biologic (oral ASA or NSAID use permitted)
- eGFR <45 ml/min/1.73 m2 calculated by CDK-EPI
- standard contraindications to MRI procedure based on MGH MRI Patient Procedure
Screening Form - including history of severe allergy to gadolinium
- use of lipid lowering agents including statin drugs, fibrates, ezetimibe, red yeast
rice, niacin or omega-3 fatty acids (>3 grams/day in standalone formulations) in the
90 days prior to study entry
- use of ACE inhibitor, ARB, or aldosterone receptor blocker in the 90 days prior to
study entry
- pregnancy or breastfeeding (female subjects of reproductive potential)
- other medical, psychiatric, or psychological condition that, in the opinion of the
study investigator, would interfere with completion of study procedures
HIV negative subjects:
Inclusion Criteria:
• age ≥40 and ≤75 years
Exclusion Criteria:
- HIV infection
- current active or recent (not fully resolved within 30 days prior to study entry)
systemic bacterial, fungal, parasitic, or viral infections (except HIV, HBV, human
papillomavirus [HPV], or HCV)
- current active cancer
- clinical ASCVD, as defined by 2013 ACC/AHA guidelines (including previous diagnosis of
AMI, ACS, stable or unstable angina, coronary or other arterial revascularization,
stroke, TIA, PAD), by subject report
- clinical diagnosis of HFpEF or HFrEF, by subject report
- diagnosed DM on antihyperglycemic medication
- current, active use of immune suppressant medication including oral or intravenous
corticosteroid or injectable biologic (oral ASA or NSAID use permitted)
- eGFR <45 ml/min/1.73 m2 calculated by CDK-EPI
- standard contraindications to MRI procedure based on MGH MRI Patient Procedure
Screening Form - including history of severe allergy to gadolinium
- use of lipid lowering agents including statin drugs, fibrates, ezetimibe, red yeast
rice, niacin or omega-3 fatty acids (>3 grams/day in standalone formulations) in the
90 days prior to study entry
- use of ACE inhibitor, ARB, or aldosterone receptor blocker in the 90 days prior to
study entry
- pregnancy or breastfeeding (female subjects of reproductive potential)
- other medical, psychiatric, or psychological condition that, in the opinion of the
study investigator, would interfere with completion of study procedures
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