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Heart FailureCOMMIT-HFNCT02536443

Contemporary Modalities in Treatment of Heart Failure

An observational study of Heart Failure, run by Silesian Centre for Heart Diseases at 1 site in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is an observational study on an all-comer systolic heart failure population hospitalized in a highly specialized cardiovascular center. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
How many people
4,000 participants
Where
1 sitePoland
Study dates
Jan 2009to Dec 2021
How long will I take part?
3 Years
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population is formed by all-comer patients hospitalized in cardiology wards and intensive cardiac care units with a diagnosis of systolic heart failure. For the purpose of this study heart failure is defined as a set of symptoms resulting from myocardial systolic function impairment, confirmed in resting transthoracic echocardiography with left ventricular ejection fraction (LVEF) ≤35%.

Who may be able to join

  • symptom based diagnosis of heart failure
  • echocardiographically confirmed impaired left ventricular ejection fraction ≤35%.

Who cannot join

  • acute coronary syndrome on admission
  • ≥ 18 years old

Trial locations and contacts

1 site in 1 country.

Lukasz Pyka, MD contact

+48502412336

pyka@vp.pl

Poland1 site, 1 recruiting

  • SIlesian Center for Heart Diseases

    Zabrze, Silesian Voivodeship, 41-800

    Lukasz Pyka, MD, +48502412336, pyka@vp.pl

    Recruiting

Other trials in Poland

About this study

The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is an observational study on an all-comer systolic heart failure population hospitalized in a highly specialized cardiovascular center. The aim of the study is to assess the clinical characteristics, treatment modalities and prognosis in this population.

Read the detailed description

The Contemporary Modalities In Treatment of Heart Failure Registry (COMMIT-HF) is a single-center observational study that is underway in the 3rd Chair and Department of Cardiology of Silesian Center for Heart Diseases in Zabrze, Poland. Data collection is patient-based (not event-based).

The main objective of the COMMIT-HF Registry is to clarify the overall clinical characteristics of systolic heart failure patients, their demographics and clinical profile, current management, in-hospital outcomes and long-term follow-up, with regard to the administered treatment.

The study population is formed by all-comer patients hospitalized in cardiology wards and intensive cardiac care units with a diagnosis of systolic heart failure. For the purpose of this study heart failure is defined as a set of symptoms resulting from myocardial systolic function impairment, confirmed in resting transthoracic echocardiography with left ventricular ejection fraction (LVEF) ≤35%. Patients with acute coronary syndromes are excluded from the analysis.

Complete patient demographics; medical history, complete hospitalization data (diagnostic and therapeutic) and in-hospital results are collected in an electronic form by the attending physician. The patients are under constant follow-up for all cause mortality and major adverse events.

Conditions
Heart Failure
Keywords
heart failure, prognosis, clinical characteristics
Medical subject headings
Heart Failure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with reported deaths from any cause

    Measured: From date of inclusion until the date of death from any cause, assessed up to 1 year

Secondary outcomes (5)

  1. Number of participants with reported heart-failure related rehospitalization

    Measured: From date of inclusion until the date of first event, assessed up to 1 year

  2. Number of participants with reported myocardial infarction

    Measured: From date of inclusion until the date of first event, assessed up to 1 year

  3. Number of participants with reported cerebrovascular insult

    Measured: From date of inclusion until the date of first event, assessed up to 1 year

  4. Number of participants to undergo mechanical circulatory support implantation

    Measured: From date of inclusion until the date implantation, assessed up to 1 year

  5. Number of participants to undergo orthotopic heart transplantation

    Measured: From date of inclusion until the date transplantation, assessed up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2015 (estimated)
  2. Study startJan 2009
  3. Primary completionDec 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
4,000 participants (estimated)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02536443
Sponsor's protocol ID
COMMIT015
Acronym
COMMIT-HF
Status last verified
May 2020
First submitted
23 Aug 2015
Last updated
22 May 2020
Results posted
No
Data monitoring committee
No

Publications

  • Gasior M, Pyka L, Gorol J, Hawranek M, Tajstra M, Slonka G, Kurek A, Krajewski A, Rozentryt P, Gierlotka M, Lekston A, Zembala M, Polonski L. COnteMporary Modalities In Treatment of Heart Failure: a report from the COMMIT-HF registry. Kardiol Pol. 2016;74(6):523-8. doi: 10.5603/KP.a2015.0224. Epub 2015 Nov 24.

    PubMed 26596896

  • Pyka L, Hawranek M, Tajstra M, Gorol J, Lekston A, Gasior M. Complete percutaneous revascularisation feasibility in ischaemic heart failure is related to improved outcomes: insights from the COMMIT-HF registry. Kardiol Pol. 2017;75(5):453-461. doi: 10.5603/KP.a2017.0018. Epub 2017 Feb 2.

    PubMed 28150287

  • Kurek A, Tajstra M, Gadula-Gacek E, Buchta P, Skrzypek M, Pyka L, Wasiak M, Swietlinska M, Hawranek M, Polonski L, Gasior M, Kosiuk J. Impact of Remote Monitoring on Long-Term Prognosis in Heart Failure Patients in a Real-World Cohort: Results From All-Comers COMMIT-HF Trial. J Cardiovasc Electrophysiol. 2017 Apr;28(4):425-431. doi: 10.1111/jce.13174. Epub 2017 Mar 7.

    PubMed 28176442

  • Wasilewski J, Pyka L, Hawranek M, Tajstra M, Skrzypek M, Wasiak M, Suliga K, Bujak K, Gasior M. Prognostic value of red blood cell distribution width in patients with left ventricular systolic dysfunction: Insights from the COMMIT-HF registry. Cardiol J. 2018;25(3):377-385. doi: 10.5603/CJ.a2017.0037. Epub 2017 Mar 29.

    PubMed 28353308

  • Wasilewski J, Pyka L, Hawranek M, Osadnik T, Kurek A, Skrzypek M, Niedziela J, Desperak P, Kulaczkowska Z, Brzezina M, Krawczyk M, Gasior M. Prognostic value of neutrophil-to-lymphocyte ratio in predicting long-term mortality in patients with ischemic and nonischemic heart failure. Pol Arch Med Wewn. 2016;126(3):166-73. doi: 10.20452/pamw.3316. Epub 2016 Mar 18.

    PubMed 26991886

  • Tajstra M, Pyka L, Gorol J, Pres D, Gierlotka M, Gadula-Gacek E, Kurek A, Wasiak M, Hawranek M, Zembala MO, Lekston A, Polonski L, Bryniarski L, Gasior M. Impact of Chronic Total Occlusion of the Coronary Artery on Long-Term Prognosis in Patients With Ischemic Systolic Heart Failure: Insights From the COMMIT-HF Registry. JACC Cardiovasc Interv. 2016 Sep 12;9(17):1790-7. doi: 10.1016/j.jcin.2016.06.007.

    PubMed 27609252

  • Siedlecki L, Szygula-Jurkiewicz B, Pyka L, Krol B, Szczurek W, Gasior M. Clinical features, management and mortality in diabetic and non-diabetic patients with heart failure - observations from the COMMIT-HF registry. Kardiochir Torakochirurgia Pol. 2017 Sep;14(3):170-174. doi: 10.5114/kitp.2017.70530. Epub 2017 Sep 30.

    PubMed 29181044

  • Szygula-Jurkiewicz B, Siedlecki L, Pyka L, Romuk E, Przybylowski P, Gasior M. Red blood cell distribution width, relative lymphocyte count, and type 2 diabetes predict all-cause mortality in patients with advanced heart failure. Pol Arch Intern Med. 2018 Feb 28;128(2):115-120. doi: 10.20452/pamw.4149. Epub 2017 Nov 9.

    PubMed 29125137

  • Dyrbus M, Machowicz J, Pyka L, Adamowicz-Czoch E, Sokola K, Pres D, Skrzypek M, Gasior M, Tajstra M. Right ventricular systolic pressure predicts outcomes in patients with cardiac resynchronization therapy defibrillators. Kardiol Pol. 2024;82(12):1239-1246. doi: 10.33963/v.phj.102981. Epub 2024 Oct 23.

    PubMed 39440742

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Silesian Centre for Heart Diseases at 1 site 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: status not confirmed, as of the sponsor's last update on 22 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Lukasz Pyka, MD (+48502412336, pyka@vp.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with reported deaths from any cause (time frame: From date of inclusion until the date of death from any cause, assessed up to 1 year). 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 NCT02536443, which also lists 9 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 22 May 2020.

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