Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-02 @ 6:14 AM
Study NCT ID:
NCT02860156
Status:
COMPLETED
Last Update Posted:
2019-03-04
First Post:
2016-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Characterizing HIV-related Diastolic Dysfunction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 195}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-28', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-08-05', 'lastUpdatePostDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'persistent inflammation between HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'Compare inflammation between HIV+/DD- and HIV+/DD+ subjects.'}, {'measure': 'immune activation between HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'Compare immune activation between HIV+/DD- and HIV+/DD+ subjects.'}, {'measure': 'inflammation between HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'To compare inflammation between HIV+/DD- and HIV+/DD+'}, {'measure': 'Perform phenomics of aggregate demographic data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit'}, {'measure': 'myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+', 'timeFrame': 'baseline visit', 'description': 'To compare myocardial fibrosis by magnetic resonance imaging between HIV+/DD- and HIV+/DD+'}, {'measure': 'serum levels of biomarkers', 'timeFrame': 'baseline visit', 'description': 'To identify systemic determinants (biomarkers) of DD in HIV+ persons'}, {'measure': 'novel mechanisms underlying DD in HIV+ subjects as measured by proteomic and metabolomics panels', 'timeFrame': 'baseline visit', 'description': 'To study the proteomic and metabolomics panels to enable identification of novel mechanisms underlying DD in HIV+ subjects'}, {'measure': 'the effect of DD on mechanics of the left atrium in HIV', 'timeFrame': 'baseline visit', 'description': 'To study the effect of DD on mechanics using left atrial strain during passive leg raise'}, {'measure': 'sub-clinical necrosis in HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'To study the sub-clinical necrosis using Troponin levels in HIV+/DD+ subjects'}, {'measure': 'myocardial stress in HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'To study myocardial stress using NTProBNP levels in HIV+/DD+ subjects'}, {'measure': 'Perform phenomics of aggregate clinical data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'Clinical data'}, {'measure': 'Perform phenomics of aggregate biomarker data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'Biomarker data'}, {'measure': 'Perform phenomics of aggregate electrocardiogram data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'electrocardiogram data'}, {'measure': 'Perform phenomics of aggregate imaging data to define risk factor phenotype signatures and relate these to HIV+/DD- and HIV+/DD+ subjects', 'timeFrame': 'baseline visit', 'description': 'imaging data'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Heart Failure', 'HIV', 'Diastolic Dysfunction']}, 'referencesModule': {'references': [{'pmid': '34365799', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age \\>40 years\n2. Willingness and ability to provide informed consent\n3. HIV antibody positive\n4. On HAART for \\>6 months (HIV positive cohort only)\n5. History of adequate viral suppression as defined by HIV RNA level \\<200 copies/mL in the past 6 months\n6. LVEF \\>50% -\n\nExclusion Criteria:\n\n1. Past EF \\<50%\n2. Moderate or severe valve stenosis or regurgitation, or past repair or replacement\n3. Percutaneous or surgical revascularization or active angina\n4. Persistent atrial fibrillation\n5. BP\\>160mmHg SBP or \\>100mmHg DBP\n6. Comorbid inflammatory disease (e.g. RA or SLE)\n7. Active cancer or cancer chemotherapy treatment in the prior year (except skin cancer that did not require chemotherapy or radiation)\n8. Chronic use of steroids or anti-inflammatory therapy\n9. GFR \\<30 mL/min\n10. Active in a clinical trial with investigational product\n11. Pregnant or lactating females\n12. Contraindication to cMR or gadolinium injection (such as severe claustrophobia, metal implants, etc.)'}, 'identificationModule': {'nctId': 'NCT02860156', 'acronym': 'HFN_HIV', 'briefTitle': 'Characterizing HIV-related Diastolic Dysfunction', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Characterizing HIV-related Diastolic Dysfunction: A Cross Sectional Study Leveraging the NHLBI Heart Failure Clinical Research Network', 'orgStudyIdInfo': {'id': 'Pro00074493'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'HIV+/DD+', 'description': 'Subjects are HIV positive and have diastolic dysfunction'}, {'label': 'HIV+/DD-', 'description': 'Subjects are HIV positive and do not have diastolic dysfunction'}, {'label': 'HIV-/DD+', 'description': 'Subjects do not have HIV and have diastolic dysfunction'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'The Emory Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tufts Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital-Washington University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospital Cleveland Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Health System', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'The University of Vermont', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}], 'overallOfficials': [{'name': 'Kevin Anstrom, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University Health Services'}, {'name': 'Eugene Braunwald, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Harvard University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}