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

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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.

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.

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
1 Barnes Jewish Hospital Plaza
Saint Louis, Missouri 63110
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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85 S Prospect St
Burlington, Vermont 5405
(802) 656-3131
University of Vermont The University of Vermont combines faculty-student relationships most commonly found in a...
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Atlanta, Georgia 30322
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Atlanta, GA
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303 East Superior Street
Chicago, Illinois 60611
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11100 Euclid Avenue
Cleveland, Ohio 44106
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Cleveland, OH
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Philadelphia, Pennsylvania 19104
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Rochester, Minnesota 55905
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Rochester, MN
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