Clinical trial NCT03056651: Day-care Unit for Patients With Refractory Heart Failure
Official title: Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Heart Diseases
Cardiovascular Diseases
Keywords: heart failure
day care
prognosis
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
First posted: 2017-02-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is an observational study on selected patients with advanced refractory heart failure. The purpose of the study was to examine the comprehensive management of HF in the day-care unit in terms of the safety and its impact on the rehospitalization and mortality rates in patients with advanced refractory HF.

Detailed description: The Day-Care Unit for Patients With Refractory Heart Failure (DayCare-HF) is a single-center observational study conducted in the 3rd Department of Cardiology, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Silesian Centre for Heart Disease in Zabrze, Poland.

The main objective of the DayCare-HF is to verify the hypothesis that comprehensive and multidisciplinary day-care management of patients with refractory heart failure (HF) is safe and beneficial in terms of hospital readmission due to HF and al cause mortality.

The study population is formed by selected patients with heart failure, hospitalized in cardiology wards and intensive cardiac care unit of Silesian Centre for Heart Disease, who fulfilled eligibility criteria.

During the scheduled visits comprehensive medical service is provided, including education, diagnostic tools (electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and additional treatment (intravenous loop diuretic, dobutamine, vasodilators administration).

The patients are under constant follow-up for major adverse events, heart transplantation, hospital readmissions due to HF and all cause mortality.

Eligibility criteria: Inclusion Criteria:

1. Optimally decongested heart failure in New York Heart Association (NYHA) class II-IV, treated for at least 6 months
2. Performance of all possible reparative procedures if indications were present (cardiac revascularization, correction of valvular heart disease, cardiac ablation, cardiac resynchronization therapy)
3. Implantation of cardioverter-defibrillator (ICD) if applicable
4. At least two unplanned hospitalizations for heart failure during preceding 6 months

Exclusion Criteria:

1. Inability to travel to the unit
2. Non-compliance with the medical recommendations

Primary outcomes:
measure: Number of participants with rehospitalization due to heart failure decompensation
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 major adverse cardiovascular event
timeFrame: From date of inclusion until the date of death from any cause, assessed up to 1 year
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
Other outcomes:
Locations:
city: Zabrze
country: Poland
facility: Silesian Centre for Heart Disease
state: Silesia
Study officials:
References: