Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-02-25 @ 11:46 PM
Study NCT ID:
NCT02275793
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2013-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054144', 'term': 'Heart Failure, Diastolic'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'DNA storage for future exploratory research into genes/genetic variations which may indicate the presence or absence of pulmonary hypertension and congestive heart failure either as an extension of this research protocol or future protocols developed in the study of pulmonary hypertension/chf'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-17', 'studyFirstSubmitDate': '2013-12-11', 'studyFirstSubmitQcDate': '2014-10-24', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '1 year', 'description': 'Checking vital statistics on each patient at one year'}], 'secondaryOutcomes': [{'measure': 'Morbidity', 'timeFrame': '1 year', 'description': 'Checking vital statistics on each patient at one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diastolic Heart Failure', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Peripheral blood and blood following a pulmonary wedge pressure will be obtained from patients undergoing right heart catheterizations.', 'detailedDescription': 'It is well known that left sided heart disease can lead to pulmonary hypertension via a number of proposed mechanisms. The purpose in this study is to identify biomarkers in pulmonary hypertension to further understand the pathophysiology of this disease in patients with heart disease.Patients are recruited in the cardiac catheterization lab, which are undergoing right heart catheterization as per their plan of care established by their primary cardiologist. During the procedure, we will ask the performing cardiologist to obtain a blood sample of 40-50 milliliters from the catheter that they are using during the procedure. These blood samples will be sent for analysis of biomarkers. The patient will then have an echocardiogram done 1 year from their heart catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will study a cohort of patients that will be recruited from the cath lab during diagnositic heart catheterization', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Ability to provide informed consent.\n* Presenting for cardiac catheterization for evaluation of heart disease\n* Ejection Fraction \\> 50%\n\nExclusion Criteria:\n\n* Unable to provide informed consent.\n* Unable or unwilling to comply with the protocol and follow up.\n* Infiltrative cardiomyopathy\n* Constrictive pericarditis\n* Severe valvular disease\n* Comorbid status with life expectancy \\<3 years\n* Right ventricular dysplasia\n* Congenital heart disease\n* On immunosuppressive drugs.\n* Patients who has heart transplant.\n* Ejection Fraction \\< 50%\n* Mean Pulmonary Artery Pressure \\<25\n* Wedge pressure \\<15'}, 'identificationModule': {'nctId': 'NCT02275793', 'acronym': 'PVR', 'briefTitle': 'The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure', 'organization': {'class': 'OTHER', 'fullName': 'University of Toledo'}, 'officialTitle': 'The Regulation of Pulmonary Vascular Resistance in Patients With Heart Failure', 'orgStudyIdInfo': {'id': 'PVR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'high PH and normal PVR', 'description': 'Group I, diastolic heart failure with high PH and normal PVR'}, {'label': 'high PH and high PVR', 'description': 'Group II, diastolic heart failure with high PH and High PVR'}, {'label': 'normal PH and normal PVR', 'description': 'Group III, no heart failure, normal PH and normal PVR'}]}, 'contactsLocationsModule': {'locations': [{'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Toledo, Health Science Campus', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}], 'overallOfficials': [{'name': 'Samer Khouri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toledo Health Science Campus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toledo Health Science Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}