Clinical trial NCT00690157: Registry of Patients Referred for Heart Transplantation
Official title: National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Heart Failure
Heart Transplantation
Keywords: heart failure, prognosis, markers,heart transplantation
Lead sponsor: National Institute of Cardiology, Warsaw, Poland
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Poland
First posted: 2008-06-04
Enrollment: 999
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced heart failure referred for orthotropic heart transplantation (OHT)

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* men and women aged \>10 years with advanced heart failure
* referred as potential candidates for orthotropic heart transplantation

Exclusion Criteria:

* refusal to participate in the registry
* not enlisted for heart transplantation (since 2006)

Primary outcomes:
measure: Death for all causes or urgent heart transplantation
timeFrame: prospective progressive 1 to 48 months
Secondary outcomes:
measure: Death without heart transplantation
timeFrame: prospective , progressive 1 to 48 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II
city: Warszawa
country: Poland
facility: Klinika Kardiochirurgii CSK MSWiA
city: Warszawa
country: Poland
facility: II Klinika Kardiochirurgii Instytutu Kardiologii
city: Warszawa
country: Poland
facility: Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii
city: Zabrze
country: Poland
facility: Śląskie Centrum Chorób Serca
Study officials:
affiliation: Śląskie Centrum Chorób Serca,Klinika Kardiochirurgii,ul. Szpitalna 2, 41-800 Zabrze
name: Marian Zembala, MD,PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Collegium Medicum Uniwersytetu Jagiellońskiego,Klinika Chirurgii Serca Naczyń i Transplantologii,ul. Prądnicka 80, 31-202 Kraków
name: Jerzy Sadowski, MD,PhD, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinika Kardiochirurgii Centralnego Szpitala Klinicznego MSWiA, ul. Wołoska 137, 02-507 Warszawa
name: Mirosław Garlicki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42
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
References:
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.
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.
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.
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.
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.