Day-care Unit for Patients With Refractory Heart Failure

Heart Failure Clinical Trial

— DayCare-HF  

Official title:

Day-care Unit for Patients With Refractory Heart Failure - a Single-centre Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03056651
• Other study ID #: DayCare-HF
• Secondary ID: DCHFU
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 2016
• Est. completion date: December 2022

Study information

• Verified date: May 2020
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Diseases
• Heart Failure

Intervention

Other:
• treatment in day-care heart failure unit

Locations

Country	Name	City	State
Poland	Silesian Centre for Heart Disease	Zabrze	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with rehospitalization due to heart failure decompensation		From date of inclusion until the date of death from any cause, assessed up to 1 year
Secondary	Number of participants with major adverse cardiovascular event		From date of inclusion until the date of death from any cause, assessed up to 1 year
Secondary	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