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

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ClinicalTrials.gov Identifier: NCT02536443
Recruitment Status : Recruiting
First Posted : August 31, 2015
Last Update Posted : September 7, 2018
Sponsor:
Information provided by (Responsible Party):
Mariusz Gasior, Silesian Centre for Heart Diseases

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.

Condition or disease
Heart Failure

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.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 4000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Contemporary Modalities in Treatment of Heart Failure
Actual Study Start Date : January 2009
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of participants with reported myocardial infarction [ Time Frame: From date of inclusion until the date of first event, assessed up to 1 year ]
  3. Number of participants with reported cerebrovascular insult [ Time Frame: 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 [ Time Frame: From date of inclusion until the date implantation, assessed up to 1 year ]
  5. Number of participants to undergo orthotopic heart transplantation [ Time Frame: From date of inclusion until the date transplantation, assessed up to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02536443


Contacts
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Contact: Lukasz Pyka, MD +48502412336 pyka@vp.pl

Locations
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Poland
SIlesian Center for Heart Diseases Recruiting
Zabrze, Silesia, Poland, 41-800
Contact: Lukasz Pyka, MD    +48502412336    pyka@vp.pl   
Sponsors and Collaborators
Silesian Centre for Heart Diseases
Investigators
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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

Additional Information:

Publications of Results:

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Responsible Party: Mariusz Gasior, Professor, PhD, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier: NCT02536443     History of Changes
Other Study ID Numbers: COMMIT015
First Posted: August 31, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Keywords provided by Mariusz Gasior, Silesian Centre for Heart Diseases:
heart failure
prognosis
clinical characteristics
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases