Contemporary Modalities in Treatment of Heart Failure

• Conditions: Heart Failure

• Registration Number: NCT02536443
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2015-08-23
• Study First Submitted QC: 2015-08-27
• Study First Posted: 2015-08-31
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-21
• Last Update Posted: 2020-05-22
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 with reported heart-failure related rehospitalization	From date of inclusion until the date of first event, 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
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 to undergo mechanical circulatory support implantation	From date of inclusion until the date implantation, assessed up to 1 year

Trial Locations

Locations (1)

SIlesian Center for Heart Diseases; 🇵🇱 Zabrze, Silesia, Poland