Registry of Patients Referred for Heart Transplantation

Heart Transplantation Clinical Trial

— POLKARD HF  

Official title:

National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00690157
• Other study ID #: POLKARD 1304/IK-AG-K-283/03
• 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

Related Conditions & MeSH terms

• Advanced Heart Failure
• Heart Failure
• Heart Transplantation

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