Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.

Not Applicable

Recruiting

• Conditions: Vaccines; Heart Failure; RSV Infection; Influenza

• Registration Number: NCT06259487
• Lead Sponsor: Wroclaw Medical University

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.

Study Timeline

• Study Start: 2023-09-15
• Status Verified: 2024-02
• Study First Submitted: 2024-02-06
• Study First Submitted QC: 2024-02-06
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.	180 days	Number of days from the intervention to the occurrence of the composite endpoint.

Trial Locations

Locations (1)

Wroclaw Medical University; 🇵🇱 Wroclaw, Dolnyslask, Poland