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

NCT ID: NCT06259487

Last Updated: 2024-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-15

Study Completion Date

2024-07-30

Brief Summary

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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

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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.

Conditions

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Heart Failure RSV Infection Influenza Vaccines

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Coordinated Vaccination

Intervention Type BIOLOGICAL

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

Standard of care

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

Group Type ACTIVE_COMPARATOR

Following recommendations

Intervention Type BEHAVIORAL

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

Interventions

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Coordinated Vaccination

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

Intervention Type BIOLOGICAL

Following recommendations

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wroclaw Medical University

OTHER

Sponsor Role lead

Responsible Party

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Jan Biegus, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wroclaw Medical University

Wroclaw, Dolnyslask, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jan Biegus, MD, PhD,

Role: CONTACT

71 736 42 05 ext. +48

Gracjan Iwanek, MD

Role: CONTACT

71 736 42 92 ext. +48

Facility Contacts

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Jan Biegus, MD, PhD

Role: primary

71 736 42 05 ext. +48

References

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Biegus J, Szenborn L, Zymlinski R, Zakliczynski M, Reczuch K, Guzik M, Urban S, Rosiek-Biegus M, Jankowiak B, Iwanek G, Fudim M, Ponikowski P. The early safety profile of simultaneous vaccination against influenza and Respiratory Syncytial Virus (RSV) in patients with high-risk heart failure. Vaccine. 2024 Apr 30;42(12):2937-2940. doi: 10.1016/j.vaccine.2024.03.060. Epub 2024 Mar 25.

Reference Type DERIVED
PMID: 38531725 (View on PubMed)

Other Identifiers

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325/2023N

Identifier Type: -

Identifier Source: org_study_id

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