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

Study on the Impact of Coordinated Immunizations Against RSV and Influenza on the Prognosis in Patients With Chronic Heart Failure.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06259487

Acronym

VACCINE-CHF

Enrollment

250

Registered

2024-02-14

Start date

2023-09-15

Completion date

2024-07-30

Last updated

2024-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Influenza, RSV Infection, Vaccines

Keywords

heart failure, RSV, Influenza, Vaccination, Immunization, Prognosis

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.

Interventions

BIOLOGICALCoordinated Vaccination

Coordinated Vaccination against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits)

BEHAVIORALFollowing recommendations

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Poland

Contacts

Primary ContactJan Biegus, MD, PhD,

jan.biegus@uwm.edu.pl71 736 42 05

Backup ContactGracjan Iwanek, MD

gracjan.iwanek@student.umw.edu.pl71 736 42 92

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026