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

February 6, 2024 updated by: Jan Biegus, MD, PhD, Wroclaw Medical University

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

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Poland
    • Dolnyslask
      • Wroclaw, Dolnyslask, Poland, 50-556
        • Recruiting
        • Wroclaw Medical University
        • Sub-Investigator:
          • Szymon Urban, MD
        • Sub-Investigator:
          • Mateusz Guzik, MD
        • Contact:
        • Principal Investigator:
          • Jan Biegus, MD, PhD
        • Principal Investigator:
          • Piotr Ponikowski, MD, PhD
        • Sub-Investigator:
          • Robert Zymliński, MD, PhD
        • Sub-Investigator:
          • Gracjan Iwanek, MD
        • Sub-Investigator:
          • Berenika Jankowiak, MD
        • Sub-Investigator:
          • Marat Fudim, MD, PhD
        • Sub-Investigator:
          • Leszek Szenborn, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coordinated Vaccination against RSV and Influenza
Patients receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e. during cardiology visits).
Biological: Coordinated Vaccination
Coordinated Vaccination against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits)
Active Comparator: Standard of care
Patients following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points).
Behavioral: Following recommendations
Guidance on following the standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wroclaw Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 30, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

February 6, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 325/2023N

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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