Study on the Impact of Coordinated Immunizations Against RSV and Influenza on the Prognosis in Patients With Chronic Heart Failure.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Wroclaw Medical University
- Enrollment
- 250
- Locations
- 1
- Primary Endpoint
- Composite endpoint: All-cause mortality, hospitalization due to heart failure, and the clinical signs of infection, characterized by a body temperature exceeding 38 degrees Celsius.
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This prospective, single-centre, open-label, randomized study aims to determine whether coordinated care in administering protective vaccinations (against Respiratory Syncytial Virus (RSV) and influenza) impacts the prognosis of patients with chronic heart failure.
The main question it aims to answer is:
• Does coordinated care through vaccinations improve the prognosis of patients with chronic heart failure?
Detailed Description
The study aims to determine whether coordinated care in the form of administering protective vaccinations affects the prognosis of patients with chronic heart failure. The study will involve analyzing epidemiological data for each participant, followed by randomization into two treatment paths: receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits) versus following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). All vaccinations will be administered using vaccines registered with the appropriate authorities and approved for use in the EU and Poland.
Investigators
Jan Biegus, MD, PhD
MD, PhD
Wroclaw Medical University
Eligibility Criteria
Inclusion Criteria
- •Age above 18 years
- •Willingness to provide informed consent for participation in the study
- •Diagnosis of heart failure
- •No previous vaccination against RSV or influenza
Exclusion Criteria
- •History of an anaphylactic reaction to vaccination
- •Hypersensitivity to any component of the vaccine
- •Receipt of vaccination against RSV or influenza in the current infectious
- •Active infection
- •Pregnancy
Outcomes
Primary Outcomes
Composite endpoint: All-cause mortality, hospitalization due to heart failure, and the clinical signs of infection, characterized by a body temperature exceeding 38 degrees Celsius.
Time Frame: 180 days
Number of days from the intervention to the occurrence of the composite endpoint.