Characterizing HIV-related Diastolic Dysfunction

NCT ID: NCT02860156

Last Updated: 2019-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 195 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-15
• Study Completion Date: 2018-02-09

Brief Summary

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.

Detailed Description

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.

Conditions

Heart Failure; HIV; Diastolic Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

HIV+/DD+

Subjects are HIV positive and have diastolic dysfunction

No interventions assigned to this group

HIV+/DD-

Subjects are HIV positive and do not have diastolic dysfunction

No interventions assigned to this group

HIV-/DD+

Subjects do not have HIV and have diastolic dysfunction

No interventions assigned to this group

Eligibility Criteria

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.)

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kevin Anstrom, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health Services

Eugene Braunwald, MD

Role: STUDY_CHAIR

Harvard University

Locations

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

Countries

United States

References

Colaco NA, Wang TS, Ma Y, Scherzer R, Ilkayeva OR, Desvigne-Nickens P, Braunwald E, Hernandez AF, Butler J, Shah SH, Shah SJ, Hsue PY. Transmethylamine-N-Oxide Is Associated With Diffuse Cardiac Fibrosis in People Living With HIV. J Am Heart Assoc. 2021 Aug 17;10(16):e020499. doi: 10.1161/JAHA.120.020499. Epub 2021 Aug 7.

Reference Type: DERIVED

PMID: 34365799 (View on PubMed)

Other Identifiers

Pro00074493

Identifier Type: -

Identifier Source: org_study_id