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CompletedNCT00690157POLKARD HFUpdated Sep 15, 2009

Registry of Patients Referred for Heart Transplantation

An observational study in Advanced Heart Failure and Heart Transplantation, sponsored by National Institute of Cardiology, Warsaw, Poland. Completed at 5 sites in Poland. Open to participants aged 10 Years and older. Per ClinicalTrials.gov, last updated 2009-09-15.

Sponsored by National Institute of Cardiology, Warsaw, Poland · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
999
Ages
10 Years and older
Sex
All
01

Study 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.

Read the 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

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Conditions studied

  • Advanced Heart Failure
  • Heart Transplantation

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Keywords

  • heart failure, prognosis, markers,heart transplantation
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In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 999 is above the median of 200 across 1,679 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

National Institute of Cardiology, Warsaw, Poland is the lead sponsor of 53 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with advanced heart failure referred for orthotropic heart transplantation (OHT)

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • refusal to participate in the registry
  • not enlisted for heart transplantation (since 2006)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
999 participants (actual)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Death for all causes or urgent heart transplantation

    Time frame: prospective progressive 1 to 48 months

Secondary outcomes

  1. Death without heart transplantation

    Time frame: prospective , progressive 1 to 48 months

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Study locations

5 sites
  • Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II
    Kraków, 31202, Poland
  • Klinika Kardiochirurgii CSK MSWiA
    Warszawa, 02-507, Poland
  • II Klinika Kardiochirurgii Instytutu Kardiologii
    Warszawa, 04-628, Poland
  • Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii
    Warszawa, 04-628, Poland
  • Śląskie Centrum Chorób Serca
    Zabrze, 41-800, Poland
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References and documents

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.
  • 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. PubMed 19950084 ↗
  • 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. PubMed 19857703 ↗
  • 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. PubMed 19857702 ↗
  • 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. PubMed 19755203 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00690157
Lead sponsor
National Institute of Cardiology, Warsaw, Poland
Collaborators
Ministry of Health, Poland
First posted
Jun 4, 2008
Start date
Oct 2003
Primary completion
Oct 2007
Completion
Oct 2007
Last update
Sep 15, 2009

Study contacts

Marian Zembala, MD,PhD, Prof
principal investigator · Śląskie Centrum Chorób Serca,Klinika Kardiochirurgii,ul. Szpitalna 2, 41-800 Zabrze
Jerzy Sadowski, MD,PhD, Prof
principal investigator · Collegium Medicum Uniwersytetu Jagiellońskiego,Klinika Chirurgii Serca Naczyń i Transplantologii,ul. Prądnicka 80, 31-202 Kraków
Mirosław Garlicki, MD, PhD
principal investigator · Klinika Kardiochirurgii Centralnego Szpitala Klinicznego MSWiA, ul. Wołoska 137, 02-507 Warszawa
Jerzy Korewicki, MD,PhD, Prof
study director · Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42
Aldona Browarek, MD, PhD
principal investigator · Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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