Clinical trial NCT02536443: Contemporary Modalities in Treatment of Heart Failure
Official title: Contemporary Modalities in Treatment of Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Keywords: heart failure
prognosis
clinical characteristics
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
First posted: 2015-08-31
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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%.

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.

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

Primary outcomes:
measure: Number of participants with reported deaths from any cause
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 1 year
Secondary outcomes:
measure: Number of participants with reported heart-failure related rehospitalization
timeFrame: From date of inclusion until the date of first event, assessed up to 1 year
measure: Number of participants with reported myocardial infarction
timeFrame: From date of inclusion until the date of first event, assessed up to 1 year
measure: Number of participants with reported cerebrovascular insult
timeFrame: From date of inclusion until the date of first event, assessed up to 1 year
measure: Number of participants to undergo mechanical circulatory support implantation
timeFrame: From date of inclusion until the date implantation, assessed up to 1 year
measure: Number of participants to undergo orthotopic heart transplantation
timeFrame: From date of inclusion until the date transplantation, assessed up to 1 year
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: SIlesian Center for Heart Diseases
state: Silesia
Study officials:
affiliation: 3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases
name: Mariusz Gasior, Prof., PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: 3rd Chair and Department of Cardiology, Silesian Center for Heart Diseases
name: Lukasz Pyka, MD
role: STUDY_CHAIR
References:
citation: 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(6):523-8. doi: 10.5603/KP.a2015.0224. Epub 2015 Nov 24.
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: 10.5603/KP.a2017.0018. Epub 2017 Feb 2.
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-Comers COMMIT-HF Trial. J Cardiovasc Electrophysiol. 2017 Apr;28(4):425-431. doi: 10.1111/jce.13174. Epub 2017 Mar 7.
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. 2018;25(3):377-385. doi: 10.5603/CJ.a2017.0037. Epub 2017 Mar 29.
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 nonischemic heart failure. Pol Arch Med Wewn. 2016;126(3):166-73. doi: 10.20452/pamw.3316. Epub 2016 Mar 18.
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 Ischemic Systolic Heart Failure: Insights From the COMMIT-HF Registry. JACC Cardiovasc Interv. 2016 Sep 12;9(17):1790-7. doi: 10.1016/j.jcin.2016.06.007.
citation: Siedlecki L, Szygula-Jurkiewicz B, Pyka L, Krol 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 Sep;14(3):170-174. doi: 10.5114/kitp.2017.70530. Epub 2017 Sep 30.
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 Feb 28;128(2):115-120. doi: 10.20452/pamw.4149. Epub 2017 Nov 9.