Characterizing HIV-related Diastolic Dysfunction

Completed

Conditions studied: Heart Failure, HIV, Diastolic Dysfunction

In brief

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.

Key facts

Study ID

NCT02860156

Run by

Duke University

People needed

195

Starts

2016-11-15

Expected to finish

2018-02-09

Last updated by the study team

2019-03-04

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >40 years
• Willingness and ability to provide informed consent
• HIV antibody positive
• On HAART for >6 months (HIV positive cohort only)
• History of adequate viral suppression as defined by HIV RNA level <200 copies/mL in the past 6 months
• LVEF >50% -

You may not qualify if…

• Past EF <50%
• Moderate or severe valve stenosis or regurgitation, or past repair or replacement
• Percutaneous or surgical revascularization or active angina
• Persistent atrial fibrillation
• BP>160mmHg SBP or >100mmHg DBP
• Comorbid inflammatory disease (e.g. RA or SLE)
• Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)
• Chronic use of steroids or anti-inflammatory therapy
• GFR <30 mL/min
• Active in a clinical trial with investigational product
• Pregnant or lactating females
• Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)

Where it is running

• The Emory Clinic — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• 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
• University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
• The University of Vermont — Burlington, Vermont, United States

Full record on ClinicalTrials.gov

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