Contemporary Modalities in Treatment of Heart Failure

Heart Failure Clinical Trial

— COMMIT-HF  

Official title:

Contemporary Modalities in Treatment of Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02536443
• Other study ID #: COMMIT015
• Status: Recruiting
• Start date: January 2009
• Est. completion date: December 2021

Study information

• Verified date: May 2020
• Source: Silesian Centre for Heart Diseases
• Contact: Lukasz Pyka, MD
• Phone: +48502412336
• Email: pyka[@]vp.pl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Locations

Country	Name	City	State
Poland	SIlesian Center for Heart Diseases	Zabrze	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

References & Publications (8)

Gasior M, Pyka L, Gorol J, Hawranek M, Tajstra M, Slonka G, Kurek A, Krajewski A, Rozentryt P, Gierlotka M, Lekston A, Zembala M, Polonski L. COnteMporary Modalities In Treatment of Heart Failure: a report from the COMMIT-HF registry. Kardiol Pol. 2016;74 — View Citation

Kurek A, Tajstra M, Gadula-Gacek E, Buchta P, Skrzypek M, Pyka L, Wasiak M, Swietlinska M, Hawranek M, Polonski L, Gasior M, Kosiuk J. Impact of Remote Monitoring on Long-Term Prognosis in Heart Failure Patients in a Real-World Cohort: Results From All-Co — View Citation

Pyka L, Hawranek M, Tajstra M, Gorol J, Lekston A, Gasior M. Complete percutaneous revascularisation feasibility in ischaemic heart failure is related to improved outcomes: insights from the COMMIT-HF registry. Kardiol Pol. 2017;75(5):453-461. doi: 10.560 — View Citation

Siedlecki L, Szygula-Jurkiewicz B, Pyka L, Król B, Szczurek W, Gasior M. Clinical features, management and mortality in diabetic and non-diabetic patients with heart failure - observations from the COMMIT-HF registry. Kardiochir Torakochirurgia Pol. 2017 — View Citation

Szygula-Jurkiewicz B, Siedlecki L, Pyka L, Romuk E, Przybylowski P, Gasior M. Red blood cell distribution width, relative lymphocyte count, and type 2 diabetes predict all-cause mortality in patients with advanced heart failure. Pol Arch Intern Med. 2018 — View Citation

Tajstra M, Pyka L, Gorol J, Pres D, Gierlotka M, Gadula-Gacek E, Kurek A, Wasiak M, Hawranek M, Zembala MO, Lekston A, Polonski L, Bryniarski L, Gasior M. Impact of Chronic Total Occlusion of the Coronary Artery on Long-Term Prognosis in Patients With Isc — View Citation

Wasilewski J, Pyka L, Hawranek M, Osadnik T, Kurek A, Skrzypek M, Niedziela J, Desperak P, Kulaczkowska Z, Brzezina M, Krawczyk M, Gasior M. Prognostic value of neutrophil-to-lymphocyte ratio in predicting long-term mortality in patients with ischemic and — View Citation

Wasilewski J, Pyka L, Hawranek M, Tajstra M, Skrzypek M, Wasiak M, Suliga K, Bujak K, Gasior M. Prognostic value of red blood cell distribution width in patients with left ventricular systolic dysfunction: Insights from the COMMIT-HF registry. Cardiol J. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of participants with reported heart-failure related rehospitalization		From date of inclusion until the date of first event, assessed up to 1 year
Secondary	Number of participants with reported myocardial infarction		From date of inclusion until the date of first event, assessed up to 1 year
Secondary	Number of participants with reported cerebrovascular insult		From date of inclusion until the date of first event, assessed up to 1 year
Secondary	Number of participants to undergo mechanical circulatory support implantation		From date of inclusion until the date implantation, assessed up to 1 year
Secondary	Number of participants to undergo orthotopic heart transplantation		From date of inclusion until the date transplantation, assessed up to 1 year