Registry of Patients Referred for Heart Transplantation
NCT ID: NCT00690157
Last Updated: 2009-09-15
Study Results
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Basic Information
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COMPLETED
999 participants
OBSERVATIONAL
2003-10-31
2007-10-31
Brief Summary
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Detailed Description
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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.
All patients with advanced heart failure referred as potential candidates for OHT in all active transplantation centers were included in the registry.
PART 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
Clinical 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.
Primary end point : Death for all causes or urgent (UNOS 1) heart transplantation Secondary end point: Death without transplantation Death or heart transplantation
Substudy POLKARD HF registry - genetic polymorphism substudy Study start date 01.04.2004 end 30.10.2007
Study population: All consecutive patients included into POLKARD HF registry, who agreed to participate and signed ICF related to the substudy.
Estimated size 350 - 450 patients.
Aims: To describe the potential impact of selected candidate genes polymorphisms on the heart failure prognosis and the survival of patients after orthotropic heart transplantation
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* referred as potential candidates for orthotropic heart transplantation
Exclusion Criteria
* not enlisted for heart transplantation (since 2006)
10 Years
ALL
No
Sponsors
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Ministry of Health, Poland
OTHER_GOV
National Institute of Cardiology, Warsaw, Poland
OTHER
Responsible Party
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Institute of Cardiology Warsaw, Poland
Principal Investigators
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Marian Zembala, MD,PhD, Prof
Role: PRINCIPAL_INVESTIGATOR
Śląskie Centrum Chorób Serca,Klinika Kardiochirurgii,ul. Szpitalna 2, 41-800 Zabrze
Jerzy Sadowski, MD,PhD, Prof
Role: PRINCIPAL_INVESTIGATOR
Collegium Medicum Uniwersytetu Jagiellońskiego,Klinika Chirurgii Serca Naczyń i Transplantologii,ul. Prądnicka 80, 31-202 Kraków
Mirosław Garlicki, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Klinika Kardiochirurgii Centralnego Szpitala Klinicznego MSWiA, ul. Wołoska 137, 02-507 Warszawa
Jerzy Korewicki, MD,PhD, Prof
Role: STUDY_DIRECTOR
Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42
Aldona Browarek, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42
Locations
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Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II
Krakow, , Poland
Klinika Kardiochirurgii CSK MSWiA
Warsaw, , Poland
II Klinika Kardiochirurgii Instytutu Kardiologii
Warsaw, , Poland
Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii
Warsaw, , Poland
Śląskie Centrum Chorób Serca
Zabrze, , Poland
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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POLKARD 1304/IK-AG-K-283/03
Identifier Type: -
Identifier Source: org_study_id
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