Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis. (VACCINE-CHF)

Wroclaw Medical University

Status: Enrolling

Conditions: Influenza; RSV Infection; Vaccines; Heart Failure

Treatments: Behavioral: Following recommendations; Biological: Coordinated Vaccination

Study type: Interventional

Funder types: Other

Identifiers

NCT06259487

325/2023N

Details and patient eligibility

About

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?

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Coordinated Vaccination against RSV and Influenza

Experimental group

Description:

Patients receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e. during cardiology visits).

Treatment:

Biological: Coordinated Vaccination

Standard of care

Active Comparator group

Description:

Patients following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points).

Treatment:

Behavioral: Following recommendations