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POLKARD HF: Registry of Patients Referred for Heart Transplantation

Sponsor
Institute of Cardiology, Warsaw, Poland (Other)
Overall Status
Completed
CT.gov ID
NCT00690157
Collaborator
Ministry of Health, Poland (Other)
999
Enrollment
5
Locations
48
Duration (Months)
199.8
Patients Per Site
4.2
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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 :
    Oct 1, 2003
    Actual Primary Completion Date :
    Oct 1, 2007
    Actual Study Completion Date :
    Oct 1, 2007

    Outcome Measures

    Primary Outcome Measures

    1. Death for all causes or urgent heart transplantation [prospective progressive 1 to 48 months]

    Secondary Outcome Measures

    1. Death without heart transplantation [prospective , progressive 1 to 48 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    10 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II Kraków Poland 31202
    2 Klinika Kardiochirurgii CSK MSWiA Warszawa Poland 02-507
    3 II Klinika Kardiochirurgii Instytutu Kardiologii Warszawa Poland 04-628
    4 Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii Warszawa Poland 04-628
    5 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00690157
    Other Study ID Numbers:
    • POLKARD 1304/IK-AG-K-283/03
    First Posted:
    Jun 4, 2008
    Last Update Posted:
    Sep 15, 2009
    Last Verified:
    Sep 1, 2009
    Keywords provided by , ,
    heart failure, prognosis, markers,heart transplantation
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Sep 15, 2009