Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT07299227
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-08-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2025-08-27', 'studyFirstSubmitQcDate': '2025-12-09', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '1a) Changes in right cardiac function (RV EF %)'}, {'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '1b) Changes in cardiac function (RV GLS%)'}, {'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '2a) Changes in pulmonary artery flow (peak flow m/s)'}, {'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '2b) Changes in pulmonary artery flow (mean flow m/s)'}, {'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '2c) Changes in pulmonary artery flow (pulse wave velocity m/s)'}], 'secondaryOutcomes': [{'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '1a) Change in LV tissue composition - T1 (ms)'}, {'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '1b) Change in LV tissue composition - ECV (%)'}, {'measure': 'Impact of BPA on cardio-pulmonary vascular physiology', 'timeFrame': '1 year', 'description': '2\\) Change in RA phasic function (%).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CTEPH', 'CMR', '4D flow'], 'conditions': ['CTEPH']}, 'descriptionModule': {'briefSummary': 'Patients with CTEPH referred for evaluation and conduction of BPA undergo standard of care diagnostic tests and treatment. This includes conventional echocardiographic, RHC and non-invasive (CT/CMR) or invasive (coronary angiography) coronary artery disease work-up. BPA will be conducted in generally 5 to 6 consecutive sessions. CMR will be performed prior to first and following the last intervention. Patient recruitment will be performed within 3 years, that is the last BPA session of the last patient in will have been performed at 3 years time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All CTEPH patients to undergo BPA', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient referred to BPA\n* clinical indication for CMR\n* capability to give informed consent\n\nExclusion Criteria:\n\n* general: non-compliance, \\<18 years of age, pregnancy\n* contraindications for CMR (non-CMR compatible device, chronic kidney disease (eGFR \\<30ml/min), allergies (medications)'}, 'identificationModule': {'nctId': 'NCT07299227', 'briefTitle': 'Impact of BPA in CTEPH on Cardiac and Pulmonary Physiology Assessed by CMR-derived 4D Flow Haemodynamics', 'organization': {'class': 'OTHER', 'fullName': 'Kerckhoff Klinik'}, 'officialTitle': 'Impact of Balloon Pulmonary Angioplasty in CTEPH on Cardiac and Pulmonary Physiology as Assessed by State-of-the-art Cardiovascular Magnetic Resonance 4D Flow Haemodynamics', 'orgStudyIdInfo': {'id': 'AZ 158/24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CTEPH patient'}]}, 'contactsLocationsModule': {'locations': [{'zip': '61231', 'city': 'Bad Nauheim', 'state': 'Hesse', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Markus Schönburg, MD', 'role': 'CONTACT', 'email': 'm.schoenburg@kerckhoff-klinik.de', 'phone': '06032-996-2620'}], 'facility': 'Kerckhoff-Klinik', 'geoPoint': {'lat': 50.36463, 'lon': 8.73859}}], 'centralContacts': [{'name': 'Sören Jan Backhaus, MD', 'role': 'CONTACT', 'email': 'soeren.backhaus@outlook.de', 'phone': '06032-996-2620'}, {'name': 'Andreas Rolf, MD', 'role': 'CONTACT', 'email': 'a.rolf@kerckhoff-klinik.de', 'phone': '06032-996-2620'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kerckhoff Klinik', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}