NCT06259487

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

10 months

First QC Date

February 6, 2024

Last Update Submit

February 6, 2024

Conditions

Heart FailureRSV InfectionInfluenzaVaccines

Keywords

heart failureRSVInfluenzaVaccinationImmunizationPrognosis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Coordinated Vaccination against RSV and Influenza

EXPERIMENTAL

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

Biological: Coordinated Vaccination

Standard of care

ACTIVE COMPARATOR

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

Behavioral: Following recommendations

Interventions

Coordinated VaccinationBIOLOGICAL

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

Coordinated Vaccination against RSV and Influenza
Following recommendationsBEHAVIORAL

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

Standard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wroclaw Medical University

Wroclaw, Dolnyslask, 50-556, Poland

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38531725DERIVED

MeSH Terms

Conditions

Heart FailureRespiratory Syncytial Virus InfectionsInfluenza, Human

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPneumovirus InfectionsParamyxoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract InfectionsOrthomyxoviridae InfectionsRespiratory Tract Diseases

Central Study Contacts

Jan Biegus, MD, PhD,

CONTACT

71 736 42 05jan.biegus@uwm.edu.pl

Gracjan Iwanek, MD

CONTACT

71 736 42 92gracjan.iwanek@student.umw.edu.pl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 6, 2024

First Posted

February 14, 2024

Study Start

September 15, 2023

Primary Completion

June 30, 2024

Study Completion

July 30, 2024

Last Updated

February 14, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)