Characterizing HIV-related Diastolic Dysfunction
Status: | Completed |
---|---|
Conditions: | Cardiology, HIV / AIDS |
Therapuetic Areas: | Cardiology / Vascular Diseases, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 40 - Any |
Updated: | 3/6/2019 |
Start Date: | November 15, 2016 |
End Date: | February 9, 2018 |
Characterizing HIV-related Diastolic Dysfunction: A Cross Sectional Study Leveraging the NHLBI Heart Failure Clinical Research Network
This is a multicenter clinical trial of a cross section of HIV+ patients with and without
diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100
HIV+/DD+ & 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers, phenomapping,
metabolomics, cMRI, echocardiography to determine characteristics unique to this patient
population.
diastolic dysfunction. Approximately 200 HAART-treated virally suppressed HIV+ subjects (100
HIV+/DD+ & 100 HIV+/DD-) will be enrolled. This study will evaluate biomarkers, phenomapping,
metabolomics, cMRI, echocardiography to determine characteristics unique to this patient
population.
With the advent of highly active antiretroviral therapy (HAART), human immuno¬deficiency
virus (HIV) type 1 infection has become a chronic disease. The proportion of patients
expected to survive 5, 10, and 15 years after conversion in the HAART era are 99%, 93% and
89% respectively. With increased life expectancy and decreased morbidity from opportunistic
infections, the importance of chronic complications associated with HIV-1 infection,
including HF is becoming more evident. The advent of HAART has altered the epidemiology of
HIV associated cardiomyopathy evolving from a primarily left ventricular systolic dysfunction
to the growing recognition of left ventricular DD. DD is associated with the development of
atrial fibrillation and heart failure (HF), and portends higher risk for all-cause mortality.
Thus there is a widespread prevalence of cardiac abnormalities in HIV infected individuals
that are associated with HF development and may represent a sub-clinical abnormality that may
be potentially intervened upon to reduce the risk of subsequent HF. There are little data to
understand the natural history and pathogenesis of cardiac abnormalities, specifically DD in
HIV+ individuals, which may adversely affect the longevity and quality of life of these
individuals.
virus (HIV) type 1 infection has become a chronic disease. The proportion of patients
expected to survive 5, 10, and 15 years after conversion in the HAART era are 99%, 93% and
89% respectively. With increased life expectancy and decreased morbidity from opportunistic
infections, the importance of chronic complications associated with HIV-1 infection,
including HF is becoming more evident. The advent of HAART has altered the epidemiology of
HIV associated cardiomyopathy evolving from a primarily left ventricular systolic dysfunction
to the growing recognition of left ventricular DD. DD is associated with the development of
atrial fibrillation and heart failure (HF), and portends higher risk for all-cause mortality.
Thus there is a widespread prevalence of cardiac abnormalities in HIV infected individuals
that are associated with HF development and may represent a sub-clinical abnormality that may
be potentially intervened upon to reduce the risk of subsequent HF. There are little data to
understand the natural history and pathogenesis of cardiac abnormalities, specifically DD in
HIV+ individuals, which may adversely affect the longevity and quality of life of these
individuals.
Inclusion Criteria:
1. Age >40 years
2. Willingness and ability to provide informed consent
3. HIV antibody positive
4. On HAART for >6 months (HIV positive cohort only)
5. History of adequate viral suppression as defined by HIV RNA level <200 copies/mL in
the past 6 months
6. LVEF >50% -
Exclusion Criteria:
1. Past EF <50%
2. Moderate or severe valve stenosis or regurgitation, or past repair or replacement
3. Percutaneous or surgical revascularization or active angina
4. Persistent atrial fibrillation
5. BP>160mmHg SBP or >100mmHg DBP
6. Comorbid inflammatory disease (e.g. RA or SLE)
7. Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer
that did not require chemotherapy or radiation)
8. Chronic use of steroids or anti-inflammatory therapy
9. GFR <30 mL/min
10. Active in a clinical trial with investigational product
11. Pregnant or lactating females
12. Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal
implants, etc.)
We found this trial at
12
sites
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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