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.
Study Type
OBSERVATIONAL
Enrollment
195
The Emory Clinic
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
persistent inflammation between HIV+/DD- and HIV+/DD+ subjects
Compare inflammation between HIV+/DD- and HIV+/DD+ subjects.
Time frame: baseline visit
immune activation between HIV+/DD- and HIV+/DD+ subjects
Compare immune activation between HIV+/DD- and HIV+/DD+ subjects.
Time frame: baseline visit
inflammation between HIV+/DD- and HIV+/DD+ subjects
To compare inflammation between HIV+/DD- and HIV+/DD+
Time frame: baseline visit
Perform phenomics of aggregate demographic data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects
Time frame: baseline visit
myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+
To compare myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+
Time frame: baseline visit
serum levels of biomarkers
To identify systemic determinants (biomarkers) of DD in HIV+ persons
Time frame: baseline visit
novel mechanisms underlying DD in HIV+ subjects as measured by proteomic and metabolomics panels
To study the proteomic and metabolomics panels to enable identification of novel mechanisms underlying DD in HIV+ subjects
Time frame: baseline visit
the effect of DD on mechanics of the left atrium in HIV
To study the effect of DD on mechanics using left atrial strain during passive leg raise
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Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes-Jewish Hospital-Washington University Hospital
St Louis, Missouri, United States
Duke University Medical Center
Durham, North Carolina, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
...and 2 more locations
Time frame: baseline visit
sub-clinical necrosis in HIV+/DD+ subjects
To study the sub-clinical necrosis using Troponin levels in HIV+/DD+ subjects
Time frame: baseline visit
myocardial stress in HIV+/DD+ subjects
To study myocardial stress using NTProBNP levels in HIV+/DD+ subjects
Time frame: baseline visit
Perform phenomics of aggregate clinical data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects
Clinical data
Time frame: baseline visit
Perform phenomics of aggregate biomarker data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects
Biomarker data
Time frame: baseline visit
Perform phenomics of aggregate electrocardiogram data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects
electrocardiogram data
Time frame: baseline visit
Perform phenomics of aggregate imaging data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects
imaging data
Time frame: baseline visit