Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2026-01-06 @ 2:02 AM
Study NCT ID:
NCT00690157
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2008-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Registry of Patients Referred for Heart Transplantation
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': 'whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 999}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2008-05-29', 'studyFirstSubmitQcDate': '2008-06-03', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Death for all causes or urgent heart transplantation', 'timeFrame': 'prospective progressive 1 to 48 months'}], 'secondaryOutcomes': [{'measure': 'Death without heart transplantation', 'timeFrame': 'prospective , progressive 1 to 48 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['heart failure, prognosis, markers,heart transplantation'], 'conditions': ['Advanced Heart Failure', 'Heart Transplantation']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Korewicki J., Browarek A., Zielinski T., Sobieszczanska-Małek M., Piotrowska M., Zembala M., Zakliczynski M., Rozentryt P., Baranska-Kosakowska A., Sadowski J., Przybyłowski P., Milaniak I., Garlicki M.: Prognosis of patients with advanced heart failure referred for heart transplantation data of POLKARD HF 2003-2005.[Rokowanie chorych z ciężką niewydolnością serca, wstępnie kwalifikowanych do przeszczepu serca - na podstawie danych ogólnopolskiego rejestru POLKARD 2003-2005.] Kardiochir. Torakochir. Pol., 2006(3): 308 - 322.'}, {'pmid': '19950084', 'type': 'DERIVED', 'citation': 'Korewicki J. Cardiac transplantation is still the method of choice in the treatment of patients with severe heart failure. Cardiol J. 2009;16(6):493-9.'}, {'pmid': '19857703', 'type': 'DERIVED', 'citation': "Zielinski T, Sobieszczanska-Malek M, Browarek A, Piotrowska M, Zakliczynski M, Przybylowski P, Roguski K, Sadowski J, Zembala M, Korewicki J; POLKARD HF investigators. The influence of the recipient's body weight on the probability to obtain a heart transplant-POLKARD HF registry. Transplant Proc. 2009 Oct;41(8):3166-70. doi: 10.1016/j.transproceed.2009.08.015."}, {'pmid': '19857702', 'type': 'DERIVED', 'citation': 'Zielinski T, Browarek A, Zembala M, Sadowski J, Zakliczynski M, Przybylowski P, Roguski K, Kosakowska AB, Korewicki J; POLKARD HF investigators. Risk stratification of patients with severe heart failure awaiting heart transplantation-prospective national registry POLKARD HF. Transplant Proc. 2009 Oct;41(8):3161-5. doi: 10.1016/j.transproceed.2009.09.049.'}, {'pmid': '19755203', 'type': 'DERIVED', 'citation': 'Zielinski T, Kurjata P, Korewicki J; participants of POLKARD-HF. Prognosis in patients with severe heart failure referred for heart transplantation--POLKARD-HF 2003-2007. Int J Cardiol. 2010 Nov 19;145(2):242-244. doi: 10.1016/j.ijcard.2009.08.026. Epub 2009 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'Main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk factors and biological markers and verification of their prognostic value in Polish population.', 'detailedDescription': 'PART I 23.10.2008- 31.12.2005 Creation of the Polish national registry of patients referred for cardiac transplantation and after heart transplantation - including urgency of qualification and prognosis.\n\nMain goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk factors and biological markers and verification of their prognostic value in Polish population.\n\nAll patients with advanced heart failure referred as potential candidates for OHT in all active transplantation centers were included in the registry.\n\nPART II 1.01.2006 -30.11.2007 Since 2006 only patients which were definitely enlisted on the waiting list for heart transplantation were included in the registry\n\nClinical and laboratory data were recorded in the internet based form. Clinical data included the etiology of the disease, NYHA class, duration of symptoms pharmacological therapy, left ventricular ejection fraction, Ergospirometric maximal oxygen uptake (V02 max) results and right heart catheterization results , ecg data of leading heart rhythm and QRS duration \\>=0,12 s and other were stored Sodium ,NTproBNP levels and hs CRP plasma levels were recorded during first 48 hours of hospitalization. All patients were followed in a prospective cohort study until the end point : death or OHT , observations were censored at the end of the study. The urgency of OHT and death data was recorded by information from participating centers and national death registry quarries.\n\nPrimary end point : Death for all causes or urgent (UNOS 1) heart transplantation Secondary end point: Death without transplantation Death or heart transplantation\n\nSubstudy POLKARD HF registry - genetic polymorphism substudy Study start date 01.04.2004 end 30.10.2007\n\nStudy population: All consecutive patients included into POLKARD HF registry, who agreed to participate and signed ICF related to the substudy.\n\nEstimated size 350 - 450 patients.\n\nAims: To describe the potential impact of selected candidate genes polymorphisms on the heart failure prognosis and the survival of patients after orthotropic heart transplantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '10 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with advanced heart failure referred for orthotropic heart transplantation (OHT)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women aged \\>10 years with advanced heart failure\n* referred as potential candidates for orthotropic heart transplantation\n\nExclusion Criteria:\n\n* refusal to participate in the registry\n* not enlisted for heart transplantation (since 2006)'}, 'identificationModule': {'nctId': 'NCT00690157', 'acronym': 'POLKARD HF', 'briefTitle': 'Registry of Patients Referred for Heart Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Cardiology, Warsaw, Poland'}, 'officialTitle': 'National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF', 'orgStudyIdInfo': {'id': 'POLKARD 1304/IK-AG-K-283/03'}}, 'contactsLocationsModule': {'locations': [{'zip': '31202', 'city': 'Krakow', 'country': 'Poland', 'facility': 'Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '02-507', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Kardiochirurgii CSK MSWiA', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-628', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'II Klinika Kardiochirurgii Instytutu Kardiologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '04-628', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}, {'zip': '41-800', 'city': 'Zabrze', 'country': 'Poland', 'facility': 'Śląskie Centrum Chorób Serca', 'geoPoint': {'lat': 50.32492, 'lon': 18.78576}}], 'overallOfficials': [{'name': 'Marian Zembala, MD,PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Śląskie Centrum Chorób Serca,Klinika Kardiochirurgii,ul. Szpitalna 2, 41-800 Zabrze'}, {'name': 'Jerzy Sadowski, MD,PhD, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Collegium Medicum Uniwersytetu Jagiellońskiego,Klinika Chirurgii Serca Naczyń i Transplantologii,ul. Prądnicka 80, 31-202 Kraków'}, {'name': 'Mirosław Garlicki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinika Kardiochirurgii Centralnego Szpitala Klinicznego MSWiA, ul. Wołoska 137, 02-507 Warszawa'}, {'name': 'Jerzy Korewicki, MD,PhD, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42'}, {'name': 'Aldona Browarek, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cardiology, Warsaw, Poland', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Poland', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Jerzy Korewicki, MD, Professor', 'oldOrganization': 'Institute of Cardiology Warsaw, Poland'}}}}