Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-04-21 @ 12:52 PM
Study NCT ID:
NCT02323750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2014-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study
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_WITH_DNA', 'description': 'Up to 100 mL blood and 40 mL urine are received for each patient at baseline and one follow-up. Samples are managed through the DZHK Heart bank collection (https://dzhk.de/en/dzhk-heart-bank).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2014-12-18', 'studyFirstSubmitQcDate': '2014-12-18', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of hospitalization for heart failure and cardiovascular death', 'timeFrame': '0.5 - 13 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systolic Dysfunction, Transition, Heart Failure, Biobank']}, 'descriptionModule': {'briefSummary': 'TransitionCHF aims to recruit a unique cohort of patients with asymptomatic left ventricular dysfunction (NYHA I) to study the progression to symptomatic (\\>NYHA I) HF and to identify parameters/ biomarkers promoting and predicting the individual risk of transition. Results from TransitionCHF Cohort Study will inform and refine current treatment guidelines. The implementation of common patient data sets and biobanking standards will enable data and biomaterial sharing with other study groups of the German Center for Cardiovascular Research (DZHK). This study will set the standard for a unique DZHK heart failure database and Biobank for innovative preclinical and clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The DZHK TransitionCHF Cohort Study will include patients with systolic dysfunction (NYHA I), i.e. (1) patients without a history of HF symptoms and (2) patients who reversed from symptomatic HF. Patients will be recruited prospectively at the participating DZHK centres, non-DZHK university hospitals and centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic systolic dysfunction (defined as: ejection fraction \\< 40% by echocardiography or MRI; documented within the last 3 months prior to baseline visit)\n* A maximum of one hospitalization for heart failure (defined as hospitalization with signs and symptoms of heart failure requiring intravenous loop diuretic therapy within 48 hours after hospital admission) at least 2 years prior to the baseline visit\n* No heart failure symptoms (NYHA II, III or IV) upon inclusion\n* 6MWD ≥ 80% of reference values\n* Written informed consent\n* Age ≥ 18 years\n\nExclusion Criteria:\n\n* Symptomatic heart failure (NYHA\\>I) at baseline visit\n* Any significant valvular disease (\\> 2nd degree)\n* Severe pulmonary disease (e.g. FEV1/FVC \\<0.7 and FEV1\\<50%)\n* Severe renal disease (GFR \\< 15 ml/min)\n* ejection fraction at baseline visit ≥ 50% by echocardiography or MRI\n* Life expectancy \\< 1 year\n* Pericardial disease\n* Hypertrophic cardiomyopathy\n* Myocardial infarction within the last 3 months\n* Planned cardiac surgical intervention within 3 months after inclusion\n* Geographical reasons (e. g. patients living outside Germany or planning to move abroad)\n* Inability to give informed consent (e. g. mental disorders)\n* Therapy with loop diuretics (e.g. torasemide, furosemide, piretanide) within 4 weeks prior to inclusion/baseline visit'}, 'identificationModule': {'nctId': 'NCT02323750', 'acronym': 'TransitionCHF', 'briefTitle': 'TransitionCHF Systolic Dysfunction to Congestive Heart Failure Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Göttingen'}, 'officialTitle': 'Systolic Dysfunction to Congestive Heart Failure Cohort Study', 'orgStudyIdInfo': {'id': 'TransitionCHF'}}, 'contactsLocationsModule': {'locations': [{'zip': '37075', 'city': 'Göttingen', 'country': 'Germany', 'facility': 'University Medical Center Goettingen', 'geoPoint': {'lat': 51.53443, 'lon': 9.93228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Göttingen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Medical Center Goettingen', 'class': 'OTHER'}, {'name': 'Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Gerd Hasenfuß', 'investigatorFullName': 'Gerd Hasenfus', 'investigatorAffiliation': 'University of Göttingen'}}}}