Advanced Heart FailurePOLKARD HFNCT00690157
Registry of Patients Referred for Heart Transplantation
An observational study of Advanced Heart Failure and Heart Transplantation, run by National Institute of Cardiology, Warsaw, Poland at 5 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Advanced Heart Failure, Heart Transplantation
- How many people
- 999 participants
- Where
- 5 sitesPoland
- Study dates
- Oct 2003to Oct 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with advanced heart failure referred for orthotropic heart transplantation (OHT)
Who may be able to join
- men and women aged >10 years with advanced heart failure
- referred as potential candidates for orthotropic heart transplantation
Who cannot join
- refusal to participate in the registry
- not enlisted for heart transplantation (since 2006)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Klinika Chirurgii Serca, Naczyń i Transplantologii, Szpital im.Jan Pawłą II
Krakow, 31202
Klinika Kardiochirurgii CSK MSWiA
Warsaw, 02-507
II Klinika Kardiochirurgii Instytutu Kardiologii
Warsaw, 04-628
Klinika Niewydolności Serca i Transplantologii Instytutu Kardiologii
Warsaw, 04-628
Śląskie Centrum Chorób Serca
Zabrze, 41-800
About this study
Official title: National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF
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
- Conditions
- Advanced Heart Failure, Heart Transplantation
- Keywords
- heart failure, prognosis, markers,heart transplantation
- Medical subject headings
- Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
Death for all causes or urgent heart transplantation
Measured: prospective progressive 1 to 48 months
Secondary outcomes (1)
Death without heart transplantation
Measured: prospective , progressive 1 to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2008 (estimated)
- Study startOct 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Advanced Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiology, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Poland
- Investigators
- Marian Zembala, MD,PhD, Prof, Principal investigator, Śląskie Centrum Chorób Serca,Klinika Kardiochirurgii,ul. Szpitalna 2, 41-800 ZabrzeJerzy Sadowski, MD,PhD, Prof, Principal investigator, Collegium Medicum Uniwersytetu Jagiellońskiego,Klinika Chirurgii Serca Naczyń i Transplantologii,ul. Prądnicka 80, 31-202 KrakówMirosław Garlicki, MD, PhD, Principal investigator, Klinika Kardiochirurgii Centralnego Szpitala Klinicznego MSWiA, ul. Wołoska 137, 02-507 WarszawaJerzy Korewicki, MD,PhD, Prof, Study director, Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42Aldona Browarek, MD, PhD, Principal investigator, Klinika Niewydolności Serca i Transplantologii, Instytut Kardiologii, 04-628 Warszawa ul.Alpejska 42
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00690157
- Sponsor's protocol ID
- POLKARD 1304/IK-AG-K-283/03
- Acronym
- POLKARD HF
- Status last verified
- Sep 2009
- First submitted
- 29 May 2008
- Last updated
- 15 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
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 19950084Zielinski 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 19857703Zielinski 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 19857702Zielinski 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF
- ClinicalTrials.gov ID
- NCT00690157
- Acronym / sponsor ID
- POLKARD HF / POLKARD 1304/IK-AG-K-283/03
- Conditions
- Advanced Heart Failure, Heart Transplantation
- Keywords
- heart failure, prognosis, markers,heart transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- National Institute of Cardiology, Warsaw, PolandUniversity, hospital or other
- Collaborators
- Ministry of Health, Poland
- Study start
- Oct 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 4 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with advanced heart failure referred for orthotropic heart transplantation (OHT)
Key inclusion criteria (2 listed)
- men and women aged >10 years with advanced heart failure
- referred as potential candidates for orthotropic heart transplantation
Key exclusion criteria (2 listed)
- refusal to participate in the registry
- not enlisted for heart transplantation (since 2006)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Death for all causes or urgent heart transplantation
Time frame: prospective progressive 1 to 48 months
1 secondary outcome
Death without heart transplantation
Time frame: prospective , progressive 1 to 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2009.
- Results publicationKorewicki 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.
- Derived from this study: PubMed 19950084Korewicki 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.
- Derived from this study: PubMed 19857703Zielinski 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.
- Derived from this study: PubMed 19857702Zielinski 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.
- Derived from this study: PubMed 19755203Zielinski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Heart Failure and Heart Transplantation, run by National Institute of Cardiology, Warsaw, Poland at 5 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death for all causes or urgent heart transplantation (time frame: prospective progressive 1 to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00690157, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2009.