NCT02536443

Brief 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. The aim of the study is to assess the clinical characteristics, treatment modalities and prognosis in this population.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2009

Completed
6.6 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 31, 2015

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

May 22, 2020

Status Verified

May 1, 2020

Enrollment Period

12.9 years

First QC Date

August 23, 2015

Last Update Submit

May 21, 2020

Conditions

Heart Failure

Keywords

heart failureprognosisclinical characteristics

Outcome Measures

Primary Outcomes (1)

  • Number of participants with reported deaths from any cause

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

Secondary Outcomes (5)

  • Number of participants with reported heart-failure related rehospitalization

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

  • Number of participants with reported myocardial infarction

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

  • Number of participants with reported cerebrovascular insult

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

  • Number of participants to undergo mechanical circulatory support implantation

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

  • Number of participants to undergo orthotopic heart transplantation

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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%.

You may qualify if:

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

You may not qualify if:

  • acute coronary syndrome on admission
  • ≥ 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SIlesian Center for Heart Diseases

Zabrze, Silesian Voivodeship, 41-800, Poland

RECRUITING

Related Publications (8)

  • 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.

    PMID: 26596896RESULT

  • 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.

    PMID: 28150287RESULT

  • 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.

    PMID: 28176442RESULT

  • 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.

    PMID: 28353308RESULT

  • 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.

    PMID: 26991886RESULT

  • 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.

    PMID: 27609252RESULT

  • 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.

    PMID: 29181044RESULT

  • 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.

    PMID: 29125137RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Mariusz Gasior, Prof., PhD

    3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases

    PRINCIPAL INVESTIGATOR

  • Lukasz Pyka, MD

    3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases

    STUDY CHAIR

Central Study Contacts

Lukasz Pyka, MD

CONTACT

+48502412336pyka@vp.pl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

August 23, 2015

First Posted

August 31, 2015

Study Start

January 1, 2009

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

May 22, 2020

Record last verified: 2020-05

Locations

PL(1)