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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00690157
Other study ID # POLKARD 1304/IK-AG-K-283/03
Secondary ID
Status Completed
Phase N/A
First received May 29, 2008
Last updated September 14, 2009
Start date October 2003
Est. completion date October 2007

Study information

Verified date September 2009
Source Institute of Cardiology, Warsaw, Poland
Contact n/a
Is FDA regulated No
Health authority Poland: Ministry of Health
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 999
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 10 Years and older
Eligibility 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)

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
Poland Klinika Chirurgii Serca, Naczyn i Transplantologii, Szpital im.Jan Pawla II Kraków
Poland II Klinika Kardiochirurgii Instytutu Kardiologii Warszawa
Poland Klinika Kardiochirurgii CSK MSWiA Warszawa
Poland Klinika Niewydolnosci Serca i Transplantologii Instytutu Kardiologii Warszawa
Poland Slaskie Centrum Chorób Serca Zabrze

Sponsors (2)

Lead Sponsor Collaborator
Institute of Cardiology, Warsaw, Poland Ministry of Health, Poland

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Korewicki J., Browarek A., Zielinski T., Sobieszczanska-Malek M., Piotrowska M., Zembala M., Zakliczynski M., Rozentryt P., Baranska-Kosakowska A., Sadowski J., Przybylowski P., Milaniak I., Garlicki M.: Prognosis of patients with advanced heart failure r

Outcome

Type Measure Description Time frame Safety issue
Primary Death for all causes or urgent heart transplantation prospective progressive 1 to 48 months No
Secondary Death without heart transplantation prospective , progressive 1 to 48 months No
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