Skip to main content
OpenTrials
Completed

NCT Number: NCT02860156

Characterizing HIV-related Diastolic Dysfunction

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Heart Failure Cardiovascular Diseases Diastolic Dysfunction HIV Heart Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Emory Clinic, Atlanta, Georgia, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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% -

Exclusion criteria

  • 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.)

Treatment and study plan

Primary outcomes

  1. persistent inflammation between HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    Compare inflammation between HIV+/DD- and HIV+/DD+ subjects.

  2. immune activation between HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    Compare immune activation between HIV+/DD- and HIV+/DD+ subjects.

  3. inflammation between HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    To compare inflammation between HIV+/DD- and HIV+/DD+

  4. 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

  5. myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+

    Time frame: baseline visit

    To compare myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+

  6. serum levels of biomarkers

    Time frame: baseline visit

    To identify systemic determinants (biomarkers) of DD in HIV+ persons

  7. novel mechanisms underlying DD in HIV+ subjects as measured by proteomic and metabolomics panels

    Time frame: baseline visit

    To study the proteomic and metabolomics panels to enable identification of novel mechanisms underlying DD in HIV+ subjects

  8. the effect of DD on mechanics of the left atrium in HIV

    Time frame: baseline visit

    To study the effect of DD on mechanics using left atrial strain during passive leg raise

  9. sub-clinical necrosis in HIV+/DD+ subjects

    Time frame: baseline visit

    To study the sub-clinical necrosis using Troponin levels in HIV+/DD+ subjects

  10. myocardial stress in HIV+/DD+ subjects

    Time frame: baseline visit

    To study myocardial stress using NTProBNP levels in HIV+/DD+ subjects

  11. Perform phenomics of aggregate clinical data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    Clinical data

  12. Perform phenomics of aggregate biomarker data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    Biomarker data

  13. Perform phenomics of aggregate electrocardiogram data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    electrocardiogram data

  14. Perform phenomics of aggregate imaging data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects

    Time frame: baseline visit

    imaging data

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Characterizing HIV-related Diastolic Dysfunction: A Cross Sectional Study Leveraging the NHLBI Heart Failure Clinical Research Network

Acronym: HFN_HIV

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 9, 2016
Registry last updated
Mar 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.