Heart FailureVACCINE-CHFNCT06259487
Coordinated Vaccination Against RSV and Influenza in Patients With Chronic Heart Failure and Its Impact on Prognosis.
A study testing Coordinated Vaccination and Following recommendations in people with Heart Failure and RSV Infection, run by Wroclaw Medical University at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, RSV Infection, Influenza
- What is being tested?
- Coordinated Vaccination and Following recommendations
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 sitePoland
- Study dates
- 15 Sep 2023to 30 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Wroclaw Medical University
Wroclaw, Dolnyslask, 50-556
Jan Biegus, MD, PhD, 71 736 42 05 ext. +48, jan.biegus@umw.edu.pl
Jan Biegus, MD, PhD
About this study
Official title: 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?
Read the 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.
- Conditions
- Heart Failure, RSV Infection, Influenza, Vaccines
- Being tested
- Coordinated Vaccination, Following recommendations
- Keywords
- heart failure, RSV, Influenza, Vaccination, Immunization, Prognosis
- Medical subject headings
- Heart Failure, Respiratory Syncytial Virus Infections, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coordinated VaccinationBiological
Coordinated Vaccination against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits)
Following recommendationsBehavioural
Guidance on following the standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: Coordinated Vaccination |
| Standard of care | Active comparator | Patients following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). Receives: Behavioral: Following recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start15 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wroclaw Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Biegus, MD, PhD, Wroclaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259487
- Sponsor's protocol ID
- 325/2023N
- Acronym
- VACCINE-CHF
- Status last verified
- Feb 2024
- First submitted
- 6 Feb 2024
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38531725
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Impact of Coordinated Immunizations Against RSV and Influenza on the Prognosis in Patients With Chronic Heart Failure.
- ClinicalTrials.gov ID
- NCT06259487
- Acronym / sponsor ID
- VACCINE-CHF / 325/2023N
- Conditions
- Heart Failure, RSV Infection, Influenza, Vaccines
- Keywords
- heart failure, RSV, Influenza, Vaccination, Immunization, Prognosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Wroclaw Medical UniversityUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jul 2024 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coordinated Vaccination against RSV and Influenza | Experimental | Biological: Coordinated VaccinationPatients receiving vaccinations against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e. during cardiology visits). |
| Standard of care | Active comparator | Behavioral: Following recommendationsPatients following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coordinated VaccinationCoordinated Vaccination against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits) | Biological | Coordinated Vaccination against RSV and Influenza |
| Following recommendationsGuidance on following the standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). | Behavioural | Standard of care |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 38531725Biegus 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coordinated Vaccination and Following recommendations in people with Heart Failure and RSV Infection, run by Wroclaw Medical University at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Biegus, MD, PhD, (71 736 42 05 ext. +48, jan.biegus@uwm.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06259487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2024.