Contemporary Modalities in Treatment of Heart Failure (COMMIT-HF)

May 21, 2020 updated by: Mariusz Gasior, Silesian Centre for Heart Diseases
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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

4000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Silesia
      • Zabrze, Silesia, Poland, 41-800
        • Recruiting
        • Silesian Center for Heart Diseases
        • Contact:
          • Lukasz Pyka, MD
          • Phone Number: +48502412336
          • Email: pyka@vp.pl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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%.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • acute coronary syndrome on admission
  • ≥ 18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with reported heart-failure related rehospitalization
Time Frame: From date of inclusion until the date of first event, assessed up to 1 year
From date of inclusion until the date of first event, assessed up to 1 year
Number of participants with reported myocardial infarction
Time Frame: From date of inclusion until the date of first event, assessed up to 1 year
From date of inclusion until the date of first event, assessed up to 1 year
Number of participants with reported cerebrovascular insult
Time Frame: From date of inclusion until the date of first event, assessed up to 1 year
From date of inclusion until the date of first event, assessed up to 1 year
Number of participants to undergo mechanical circulatory support implantation
Time Frame: From date of inclusion until the date implantation, assessed up to 1 year
From date of inclusion until the date implantation, assessed up to 1 year
Number of participants to undergo orthotopic heart transplantation
Time Frame: From date of inclusion until the date transplantation, assessed up to 1 year
From date of inclusion until the date transplantation, assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Silesian Centre for Heart Diseases

Investigators

  • Principal Investigator: Mariusz Gasior, Prof., PhD, 3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases
  • Study Chair: Lukasz Pyka, MD, 3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2009

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

August 23, 2015

First Submitted That Met QC Criteria

August 27, 2015

First Posted (Estimate)

August 31, 2015

Study Record Updates

Last Update Posted (Actual)

May 22, 2020

Last Update Submitted That Met QC Criteria

May 21, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COMMIT015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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