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Characterizing HIV-related Diastolic Dysfunction (HFN_HIV)

Duke University logo

Duke University

Status

Completed

Conditions

Diastolic Dysfunction
HIV
Heart Failure

Study type

Observational

Funder types

Other

Identifiers

NCT02860156
Pro00074493

Details and patient eligibility

About

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.

Full 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.

Enrollment

195 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.)

Trial design

195 participants in 3 patient groups

HIV+/DD+
Description:
Subjects are HIV positive and have diastolic dysfunction
HIV+/DD-
Description:
Subjects are HIV positive and do not have diastolic dysfunction
HIV-/DD+
Description:
Subjects do not have HIV and have diastolic dysfunction

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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