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Heart FailureHFN_HIVNCT02860156

Characterizing HIV-related Diastolic Dysfunction

An observational study of Heart Failure and HIV, run by Duke University at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Heart Failure, HIV, Diastolic Dysfunction
How many people
195 participants
Where
12 sitesUnited States
Study dates
15 Nov 2016to 9 Feb 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Subjects who are receiving care at a site participating in the Heart Failure Clinical Research Network program, are HIV positive, have been on HAART for >6 months and are virally suppressed will be screened for participation.

Who may be able to join

  • 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% -

Who cannot join

  • 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)
Show all 12Show fewer
  • 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.)

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • The Emory Clinic

    Atlanta, Georgia, 30322

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • The University of Vermont

    Burlington, Vermont, 05401

  • Northwestern University

    Chicago, Illinois, 60611

  • University Hospital Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania Health System

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Barnes-Jewish Hospital-Washington University Hospital

    St Louis, Missouri, 63110

Other trials in United States

About this study

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

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.

Read the 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.

Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02860156
Study groupRoleWhat they receive
HIV+/DD+Subjects are HIV positive and have diastolic dysfunction
HIV+/DD-Subjects are HIV positive and do not have diastolic dysfunction
HIV-/DD+Subjects do not have HIV and have diastolic dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: baseline visit

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

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

    Measured: baseline visit

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

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

    Measured: baseline visit

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

    Measured: baseline visit

  5. 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+

    Measured: baseline visit

  6. serum levels of biomarkers

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

    Measured: baseline visit

  7. 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

    Measured: baseline visit

  8. 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

    Measured: baseline visit

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

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

    Measured: baseline visit

  10. myocardial stress in HIV+/DD+ subjects

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

    Measured: baseline visit

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

    Clinical data

    Measured: baseline visit

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

    Biomarker data

    Measured: baseline visit

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

    electrocardiogram data

    Measured: baseline visit

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

    imaging data

    Measured: baseline visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completion9 Feb 2018
  4. Study completion9 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02860156
Sponsor's protocol ID
Pro00074493
Acronym
HFN_HIV
Status last verified
Feb 2019
First submitted
28 Jul 2016
Last updated
4 Mar 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 34365799

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure and HIV, run by Duke University at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

persistent inflammation between HIV+/DD- and HIV+/DD+ subjects (time frame: baseline visit). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02860156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2019.

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