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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
Sponsor:
Collaborator:
Information provided by:

Study Description
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.

Condition or disease
Advanced Heart Failure Heart Transplantation

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


Study Design

Study Type : Observational
Actual Enrollment : 999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF
Study Start Date : October 2003
Primary Completion Date : October 2007
Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Death for all causes or urgent heart transplantation [ Time Frame: prospective progressive 1 to 48 months ]

Secondary Outcome Measures :
  1. Death without heart transplantation [ Time Frame: prospective , progressive 1 to 48 months ]

Biospecimen Retention:   Samples With DNA
whole blood

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced heart failure referred for orthotropic heart transplantation (OHT)
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)
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690157


Locations
Poland
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
Sponsors and Collaborators
Institute of Cardiology, Warsaw, Poland
Ministry of Health, Poland
Investigators
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
More Information

Publications:
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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jerzy Korewicki, MD, Professor, Institute of Cardiology Warsaw, Poland
ClinicalTrials.gov Identifier: NCT00690157     History of Changes
Other Study ID Numbers: POLKARD 1304/IK-AG-K-283/03
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by Institute of Cardiology, Warsaw, Poland:
heart failure, prognosis, markers,heart transplantation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases