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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?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Standard of care | Active Comparator | Patients following standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coordinated Vaccination | Biological | Coordinated Vaccination against Respiratory Syncytial Virus (RSV) and influenza provided by the research team (i.e., during cardiology visits) |
| 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. | Number of days from the intervention to the occurrence of the composite endpoint. | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Biegus, MD, PhD, | Contact | 71 736 42 05 | +48 | jan.biegus@uwm.edu.pl |
| Gracjan Iwanek, MD | Contact | 71 736 42 92 | +48 | gracjan.iwanek@student.umw.edu.pl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wroclaw Medical University | Recruiting | Wroclaw | Dolnyslask | 50-556 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38531725 | Derived | 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. |
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| Following recommendations | Behavioral | Guidance on following the standard recommendations for protective vaccinations (i.e., receiving vaccinations at vaccination points). |
|
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D018357 | Respiratory Syncytial Virus Infections |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D009976 | Orthomyxoviridae Infections |
| D012140 | Respiratory Tract Diseases |
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