Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT00207220
Status:
COMPLETED
Last Update Posted:
2007-11-09
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ventricular-Vascular Coupling in Heart Failure
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-11', 'completionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-11-07', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2007-11-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure', 'preserved ejection fraction', 'vascular stiffness'], 'conditions': ['Heart Failure With Preserved Ejection Fraction']}, 'descriptionModule': {'briefSummary': 'This study will test the hypothesis that increases in ventricular-vascular stiffness can be demonstrated by arterial tonometry and echocardiography in subjects with heart failure with preserved ejection fraction (HF-nlEF)(i.e. normal left ventricular function.) We will also track changes in pulsatile hemodynamics over time in subjects hospitalized with HF-nlEF.', 'detailedDescription': 'The pathophysiologic mechanisms responsible for the development of heart failure in people with preserved ejection fraction (i.e. normal left ventricular function) remain poorly understood. One possible mechanism may be the contribution of increased arterial stiffness to changes in pulsatile hemodynamic load during ventricular systole, implicating abnormal ventricular-vascular interactions throughout the cardiac cycle in the pathogenesis of heart failure with normal ejection fraction.\n\nTo investigate changes in ventricular-vascular stiffness in subjects with heart failure and normal left ventricular function, comparisons will be made between 3 distinct sub-populations:\n\n* subjects with heart failure and normal ejection fraction\n* non-diabetic hypertensive controls\n* normotensive controls'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'adults with heart failure and preserved left ventricular function', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects with heart failure and preserved ejection fraction\n\n* clinical signs of heart failure\n* serum brain natriuretic peptide (BNP) \\>100pg/mL\n* NYHA functional class II-IV\n* left ventricular ejection fraction(LVEF) \\>=50% measured by echocardiography\n* Non-diabetic subjects with hypertension\n* treated or untreated essential hypertension\n* LVEF \\>=50% measured by echocardiography\n\nDiabetic subjects with hypertension\n\n* Type 2 diabetes\n* treated or untreated essential hypertension\n* LVEF \\>=50% measured by echocardiography\n\nNormotensive control subjects\n\n* normal blood pressure (i.e. \\< 140/90 mmHg)\n* LVEF \\>=50% measured by echocardiography\n\nExclusion Criteria:\n\nSubjects with heart failure and preserved ejection fraction\n\n* atrial fibrillation\n* symptoms of angina or a myocardial infarction (MI) within 6 months\n* known significant coronary artery disease (CAD) (stenosis \\> 70%)\n* significant valvular heart disease\n* restrictive/constrictive heart disease\n* inability to lie flat for procedure (estimated duration 1 hour)\n\nNon-diabetic subjects with hypertension\n\n* atrial fibrillation\n* symptoms of angina or a myocardial infarction (MI) within 6 months\n* known significant coronary artery disease (CAD) (stenosis \\> 70%)\n* significant valvular heart disease\n* restrictive/constrictive heart disease\n* inability to lie flat for procedure (estimated duration 1 hour)\n* prior history of heart failure or unexplained dyspnea\n\nDiabetic subjects with hypertension\n\n* atrial fibrillation\n* symptoms of angina or a myocardial infarction (MI) within 6 months\n* known significant coronary artery disease (CAD) (stenosis \\> 70%)\n* significant valvular heart disease\n* restrictive/constrictive heart disease\n* inability to lie flat for procedure (estimated duration 1 hour)\n* prior history of heart failure or unexplained dyspnea\n\nNormotensive control subjects\n\n* prior history of structural heart disease or ventricular hypertrophy\n* treatment with HMG-Co(A)reductase inhibitors (statins)\n* anti-hypertensive medications\n* cigarette smoking\n* cocaine use\n* excessive alcohol intake'}, 'identificationModule': {'nctId': 'NCT00207220', 'briefTitle': 'Ventricular-Vascular Coupling in Heart Failure', 'organization': {'class': 'OTHER', 'fullName': "Brigham and Women's Hospital"}, 'officialTitle': 'Ventricular-Vascular Coupling in Patients With Heart Failure and Preserved Ejection Fraction', 'orgStudyIdInfo': {'id': '2003P-001769'}}, 'armsInterventionsModule': {'armGroups': [{'label': '3', 'description': 'subjects with heart failure and normal ejection fraction non-diabetic hypertensive controls hypertensive diabetic controls normotensive controls', 'interventionNames': ['Procedure: arterial tonometry', 'Procedure: echocardiography']}], 'interventions': [{'name': 'arterial tonometry', 'type': 'PROCEDURE', 'otherNames': ['PAT'], 'description': 'used to determine peripheral arterial vascular tone by measuring blood pressure waveforms via a probe attached to the finger.', 'armGroupLabels': ['3']}, {'name': 'echocardiography', 'type': 'PROCEDURE', 'otherNames': ['cardiac echo'], 'description': 'ultrasound test using sound waves to create a moving picture of the heart', 'armGroupLabels': ['3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham & Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Mark Creager, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Brigham and Women's Hospital"}, {'name': 'Akshay S. Desai, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': "Brigham and Women's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Brigham and Women's Hospital", 'class': 'OTHER'}}}}