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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 4, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date July 28, 2016
First Posted Date August 9, 2016
Last Update Posted Date March 4, 2019
Actual Study Start Date November 15, 2016
Actual Primary Completion Date February 9, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2016)
  • persistent inflammation between HIV+/DD- and HIV+/DD+ subjects [ Time Frame: baseline visit ]
    Compare inflammation between HIV+/DD- and HIV+/DD+ subjects.
  • immune activation between HIV+/DD- and HIV+/DD+ subjects [ Time Frame: baseline visit ]
    Compare immune activation between HIV+/DD- and HIV+/DD+ subjects.
  • inflammation between HIV+/DD- and HIV+/DD+ subjects [ Time Frame: baseline visit ]
    To compare inflammation between HIV+/DD- and HIV+/DD+
  • 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 ]
  • 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+
  • serum levels of biomarkers [ Time Frame: baseline visit ]
    To identify systemic determinants (biomarkers) of DD in HIV+ persons
  • 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
  • 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
  • sub-clinical necrosis in HIV+/DD+ subjects [ Time Frame: baseline visit ]
    To study the sub-clinical necrosis using Troponin levels in HIV+/DD+ subjects
  • myocardial stress in HIV+/DD+ subjects [ Time Frame: baseline visit ]
    To study myocardial stress using NTProBNP levels in HIV+/DD+ subjects
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02860156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Characterizing HIV-related Diastolic Dysfunction
Official Title Characterizing HIV-related Diastolic Dysfunction: A Cross Sectional Study Leveraging the NHLBI Heart Failure Clinical Research Network
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.
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
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Plasma
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.
Condition
  • Heart Failure
  • HIV
  • Diastolic Dysfunction
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Butler J, Greene SJ, Shah SH, Shah SJ, Anstrom KJ, Kim RJ, Kalogeropoulos AP, Velazquez EJ, Hernandez AF, Desvigne-Nickens P, Scherzer R, Hsue PY, Braunwald E. Diastolic Dysfunction in Patients with Human Immunodeficiency Virus Receiving Antiretroviral Therapy: Results from the CHART Study. J Card Fail. 2019 Nov 1. pii: S1071-9164(19)30584-6. doi: 10.1016/j.cardfail.2019.10.011. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 26, 2018)
195
Original Estimated Enrollment
 (submitted: August 5, 2016)
200
Actual Study Completion Date February 9, 2018
Actual Primary Completion Date February 9, 2018   (Final data collection date for primary outcome measure)
Eligibility 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.)
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02860156
Other Study ID Numbers Pro00074493
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Not Provided
Investigators
Principal Investigator: Kevin Anstrom, PhD Duke University Health Services
Study Chair: Eugene Braunwald, MD Harvard University
PRS Account Duke University
Verification Date February 2019