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

Heart Failure Clinical Trial

— VACCINE-CHF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06259487
• Other study ID #: 325/2023N
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: February 2024
• Source: Wroclaw Medical University
• Contact: Jan Biegus, MD, PhD,
• Phone: 71 736 42 05
• Email: jan.biegus[@]uwm.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Influenza
• Influenza, Human
• Respiratory Syncytial Virus Infections
• RSV Infection
• Vaccines

Intervention

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

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

Locations

Country	Name	City	State
Poland	Wroclaw Medical University	Wroclaw	Dolnyslask

Sponsors (1)

Lead Sponsor	Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Number of days from the intervention to the occurrence of the composite endpoint.	180 days