NCT00690157

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
999

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
Last Updated

September 15, 2009

Status Verified

September 1, 2009

Enrollment Period

4 years

First QC Date

May 29, 2008

Last Update Submit

September 14, 2009

Conditions

Advanced Heart FailureHeart Transplantation

Keywords

heart failure, prognosis, markers,heart transplantation

Outcome Measures

Primary Outcomes (1)

  • Death for all causes or urgent heart transplantation

    prospective progressive 1 to 48 months

Secondary Outcomes (1)

  • Death without heart transplantation

    prospective , progressive 1 to 48 months

Eligibility Criteria

Age10 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II

Krakow, 31202, Poland

Location

Klinika Kardiochirurgii CSK MSWiA

Warsaw, 02-507, Poland

Location

II Klinika Kardiochirurgii Instytutu Kardiologii

Warsaw, 04-628, Poland

Location

Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii

Warsaw, 04-628, Poland

Location

Śląskie Centrum Chorób Serca

Zabrze, 41-800, Poland

Location

Related Publications (5)

  • 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.

    RESULT

  • 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.

    PMID: 19950084DERIVED

  • 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.

    PMID: 19857703DERIVED

  • 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.

    PMID: 19857702DERIVED

  • 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.

    PMID: 19755203DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

  • Jerzy Korewicki, MD,PhD, Prof

    Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42

    STUDY DIRECTOR

  • Aldona Browarek, MD, PhD

    Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2008

First Posted

June 4, 2008

Study Start

October 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

September 15, 2009

Record last verified: 2009-09

Locations

PL(5)