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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

Tracking Information
First Submitted Date August 23, 2015
First Posted Date August 31, 2015
Last Update Posted Date September 7, 2018
Actual Study Start Date January 2009
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 27, 2015)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02536443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 27, 2015)
  • 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 ]
  • Number of participants with reported myocardial infarction [ Time Frame: 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 ]
  • Number of participants to undergo mechanical circulatory support implantation [ Time Frame: 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Contemporary Modalities in Treatment of Heart Failure
Official Title Contemporary Modalities in Treatment of Heart Failure
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.
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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
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%.
Condition Heart Failure
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 27, 2015)
4000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Lukasz Pyka, MD +48502412336 pyka@vp.pl
Listed Location Countries Poland
Removed Location Countries  
 
Administrative Information
NCT Number NCT02536443
Other Study ID Numbers COMMIT015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mariusz Gasior, Silesian Centre for Heart Diseases
Study Sponsor Silesian Centre for Heart Diseases
Collaborators Not Provided
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
PRS Account Silesian Centre for Heart Diseases
Verification Date September 2018