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Trial record 3 of 4 for:    diastolic dysfunction | Hiv | United States

Characterizing HIV-related Diastolic Dysfunction (HFN_HIV)

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ClinicalTrials.gov Identifier: NCT02860156
Recruitment Status : Completed
First Posted : August 9, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Heart Failure HIV Diastolic Dysfunction

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.

Study Type : Observational
Actual Enrollment : 195 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Characterizing HIV-related Diastolic Dysfunction: A Cross Sectional Study Leveraging the NHLBI Heart Failure Clinical Research Network
Actual Study Start Date : November 15, 2016
Actual Primary Completion Date : February 9, 2018
Actual Study Completion Date : February 9, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Group/Cohort
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



Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Plasma


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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02860156


Locations
United States, Georgia
The Emory Clinic
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Barnes-Jewish Hospital-Washington University Hospital
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19104
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
United States, Vermont
The University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Kevin Anstrom, PhD Duke University Health Services
Study Chair: Eugene Braunwald, MD Harvard University

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02860156     History of Changes
Other Study ID Numbers: Pro00074493
First Posted: August 9, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases