Day-care Unit for Patients With Refractory Heart Failure

NCT ID: NCT03056651

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2022-12-31

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.

Conditions

Heart Failure; Heart Diseases; Cardiovascular Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DayCare-HF

Comprehensive service in day-care unit, including education, diagnostic tools (i.e. electrocardiography, transthoracic echocardiography, implanted cardioverter defibrillator (ICD) / cardiac resynchronization therapy device (CRT) interrogation and possibility of intravenous drug administration (i.e. loop diuretics, dobutamine).

Group Type: OTHER

treatment in day-care heart failure unit

Intervention Type: OTHER

Interventions

treatment in day-care heart failure unit

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Silesian Centre for Heart Diseases

OTHER

Sponsor Role: lead

Responsible Party

Mariusz Gasior

MD, PhD, Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Silesian Centre for Heart Disease

Zabrze, Silesian Voivodeship, Poland

Countries

Poland

Other Identifiers

DCHFU

Identifier Type: OTHER

Identifier Source: secondary_id

DayCare-HF

Identifier Type: -

Identifier Source: org_study_id