Contemporary Modalities in Treatment of Heart Failure (COMMIT-HF)
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| ClinicalTrials.gov Identifier: NCT02536443 |
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Recruitment Status :
Recruiting
First Posted : August 31, 2015
Last Update Posted : September 7, 2018
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| Condition or disease |
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| Heart Failure |
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] |
| 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 |
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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
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
| Contact: Lukasz Pyka, MD | +48502412336 | pyka@vp.pl |
| Poland | |
| SIlesian Center for Heart Diseases | Recruiting |
| Zabrze, Silesia, Poland, 41-800 | |
| Contact: Lukasz Pyka, MD +48502412336 pyka@vp.pl | |
| 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:
| 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 |
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heart failure prognosis clinical characteristics |
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Heart Failure Heart Diseases Cardiovascular Diseases |