NCT02860156

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
195

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2018

Completed
Last Updated

March 4, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

July 28, 2016

Last Update Submit

February 28, 2019

Conditions

Heart FailureHIVDiastolic Dysfunction

Outcome Measures

Primary Outcomes (14)

  • persistent inflammation between HIV+/DD- and HIV+/DD+ subjects

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

    baseline visit

  • immune activation between HIV+/DD- and HIV+/DD+ subjects

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

    baseline visit

  • inflammation between HIV+/DD- and HIV+/DD+ subjects

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

    baseline visit

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

    baseline visit

  • 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+

    baseline visit

  • serum levels of biomarkers

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

    baseline visit

  • 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

    baseline visit

  • 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

    baseline visit

  • sub-clinical necrosis in HIV+/DD+ subjects

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

    baseline visit

  • myocardial stress in HIV+/DD+ subjects

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

    baseline visit

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

    Clinical data

    baseline visit

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

    Biomarker data

    baseline visit

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

    electrocardiogram data

    baseline visit

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

    imaging data

    baseline visit

Study Arms (3)

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The Emory Clinic

Atlanta, Georgia, 30322, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital-Washington University Hospital

St Louis, Missouri, 63110, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University Hospital Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

The University of Vermont

Burlington, Vermont, 05401, United States

Location

Related Publications (1)

  • 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.

    PMID: 34365799DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Kevin Anstrom, PhD

    Duke University Health Services

    PRINCIPAL INVESTIGATOR

  • Eugene Braunwald, MD

    Harvard University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2016

First Posted

August 9, 2016

Study Start

November 15, 2016

Primary Completion

February 9, 2018

Study Completion

February 9, 2018

Last Updated

March 4, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

US(12)