Ignite Creation Date:
2025-12-24 @ 9:37 PM
Ignite Modification Date:
2025-12-25 @ 7:20 PM
Study NCT ID:
NCT06656832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-24
First Post:
2024-10-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The primary endpoint (NT-proBNP) will be measured by lab personnel blinded to patients´ group assignment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2024-10-22', 'studyFirstSubmitQcDate': '2024-10-22', 'lastUpdatePostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in NT-proBNP plasma levels between baseline and 6 months visit', 'timeFrame': '6 months', 'description': 'Adjusted geometric mean ratio between 6 months visit and baseline visit'}], 'secondaryOutcomes': [{'measure': 'Change in KCCQ from baseline to 6 months of Follow-up', 'timeFrame': '6 months', 'description': 'Quality of life measured by Kansas City Cardiomyopathy Questionnaire'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure Network Care'], 'conditions': ['Heart Failure - NYHA II - IV']}, 'descriptionModule': {'briefSummary': 'PEDAL-HF is a registry-based randomized prospective multicenter study. We plan to include 1000 patients who were recently admitted with acute decompensated heart failure at five tertiary heart clinics in Germany. For the randomised part, 750 patients will be randomized to care within a heart failure network or usual care. The primary endpoint of the randomized trial is change in NT-proBNP from baseline to 6 months of follow-up.\n\nAll patients (randomized or not) will be followed for two years.', 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to the participating study centres with acute decompensated heart failure (ADHF), defined as clinical signs and/or symptoms of heart failure, objective structural cardiac abnormalitites according to the ESC criteria.\n\nExclusion Criteria:\n\n* Age \\< 18 years, pregnancy, any condition interfering with the informed consent process, patients placed in an institution by official or court order'}, 'identificationModule': {'nctId': 'NCT06656832', 'acronym': 'PEDAL-HF', 'briefTitle': 'Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Leipzig'}, 'officialTitle': 'Peripheral Drivers of Heart Failure Progression - the Prospective PEDAL-HF Study', 'orgStudyIdInfo': {'id': '242/24-ek'}, 'secondaryIdInfos': [{'id': '934700-034', 'type': 'OTHER', 'domain': 'Universität Leipzig'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Randomised Arm 1: Heart Failure Network Care', 'description': 'Patients will receive three follow-up visits during the vulnerable period (three month after hospital discharge) in the HF network (either cardiologist in private practice or HF outpatient clinic)', 'interventionNames': ['Other: Heart Failure network care']}, {'type': 'NO_INTERVENTION', 'label': 'Randomised Arm 2: Usual care', 'description': 'Patients will receive usual care by their primary physician or cardiologist'}, {'type': 'NO_INTERVENTION', 'label': 'Registry Arm for non-randomised patients', 'description': 'Patients not willing to be randomised will be followed in a registry.'}], 'interventions': [{'name': 'Heart Failure network care', 'type': 'OTHER', 'description': 'Patients will receive three visits within the first three months after randomization for improving heart failure therapy at a cardiologist or the outpatient heart failure clinic', 'armGroupLabels': ['Randomised Arm 1: Heart Failure Network Care']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Rolf Wachter, MD', 'role': 'CONTACT', 'email': 'rolf.wachter@medizin.uni-leipzig.de', 'phone': '+49-341-97-12650'}, {'name': 'Sophie Charlotte Schröder, MD', 'role': 'CONTACT', 'email': 'sophiecharlotte.schroeder@medizin.uni-leipzig.de', 'phone': '+49-341-97-12650'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Individual patient data will be shared following reasonable scientific request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Leipzig', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}