Registry of Patients Referred for Heart Transplantation (POLKARD HF)
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|ClinicalTrials.gov Identifier: NCT00690157|
Recruitment Status : Completed
First Posted : June 4, 2008
Last Update Posted : September 15, 2009
|Condition or disease|
|Advanced Heart Failure Heart Transplantation|
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.
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
|Study Type :||Observational|
|Actual Enrollment :||999 participants|
|Official Title:||National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF|
|Study Start Date :||October 2003|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
- Death for all causes or urgent heart transplantation [ Time Frame: prospective progressive 1 to 48 months ]
- Death without heart transplantation [ Time Frame: prospective , progressive 1 to 48 months ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690157
|Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II|
|Kraków, Poland, 31202|
|Klinika Kardiochirurgii CSK MSWiA|
|Warszawa, Poland, 02-507|
|II Klinika Kardiochirurgii Instytutu Kardiologii|
|Warszawa, Poland, 04-628|
|Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii|
|Warszawa, Poland, 04-628|
|Śląskie Centrum Chorób Serca|
|Zabrze, Poland, 41-800|
|Principal Investigator:||Marian Zembala, MD,PhD, Prof||Śląskie Centrum Chorób Serca,Klinika Kardiochirurgii,ul. Szpitalna 2, 41-800 Zabrze|
|Principal Investigator:||Jerzy Sadowski, MD,PhD, Prof||Collegium Medicum Uniwersytetu Jagiellońskiego,Klinika Chirurgii Serca Naczyń i Transplantologii,ul. Prądnicka 80, 31-202 Kraków|
|Principal Investigator:||Mirosław Garlicki, MD, PhD||Klinika Kardiochirurgii Centralnego Szpitala Klinicznego MSWiA, ul. Wołoska 137, 02-507 Warszawa|
|Study Director:||Jerzy Korewicki, MD,PhD, Prof||Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42|
|Principal Investigator:||Aldona Browarek, MD, PhD||Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42|