Timing of Influenza Vaccination in Patients With Heart Failure

Heart Failure Clinical Trial

— FLU-HF  

Official title:

Optimizing the Timing of Influenza Vaccination in Patients With Heart Failure: the FLU-HF Randomized Trial: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05507502
• Other study ID #: 2021-7425
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: August 2022
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Dina Moawad, MSc.
• Phone: (514) 934-1934
• Email: dina.moawad[@]muhc.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Heart failure (HF) is one of the most common causes of hospital admission in Canada and costs the Canadian healthcare system over $1 billion annually. Influenza vaccination is an inexpensive strategy to prevent influenza infections and reduce an important trigger for HF decompensation and hospital readmission. Yet, the optimal timing of vaccine administration remains unclear. When patients with HF are admitted to the hospital with an acute decompensation in advance of, or during, the 'flu season', this can be an ideal time to administer the vaccine. However, patients with acute HF decompensation have significant inflammatory injury, and may have substantially impaired immune responses; thus vaccine administration while admitted during an acute decompensated HF episode may not lead to high anti-influenza antibody titres. A more effective strategy can be to vaccinate after the decompensation has resolved, when patients are more stable. The FLU-HF randomized trial will determine whether administering the influenza vaccine to patients admitted in-hospital with an acute HF decompensation or waiting until they have stabilized as an out-patient leads to an improved anti-influenza response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years
• Admitted in hospital with primary diagnosis of acute HF
• Prior diagnosis of chronic HF > 3 months prior to admission
• Not on inotropes, mechanical support, or IV diuretics for 24 hours
• Able to follow-up within the MUHC HF clinic as per schedule
• agree to receive influenza vaccination

Exclusion Criteria:

• Any person who does not meet the above criteria and/or who refuses to participate
• Already received this seasons influenza vaccination
• Known allergy to influenza vaccination or components of the influenza vaccination
• Unlikely to survive to discharge as per admitting physician
• Prior organ transplant
• Undergoing chemotherapy for active malignancy
• Currently randomized in another clinical study

Related Conditions & MeSH terms

• Heart Failure

Intervention

Biological:
• Influenza vaccination administration
There will be approximately 40 participants who consent; they will be randomized in a 1:1 manner to receiving the influenza vaccination during their heart failure hospitalization versus receiving the vaccine during their first follow-up in the heart failure clinic.

Locations

Country	Name	City	State
Canada	McGill University Health Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Abhinav Sharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Seroconversion for one or more strains in the influenza vaccine upto three months following vaccination.	Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.	Randomization to three months post randomization
Other	Change in NTproBNP	Serologic blood work measured at randomization and post-randomization	Randomization to three months post randomization
Other	Change in high-sensitivity troponin	Serologic blood work measured at randomization and post-randomization	Randomization to three months post randomization
Other	Changes in inflammatory markers	Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization	Randomization to three months post randomization
Primary	Seroconversion for one or more strains in the influenza vaccine one month following vaccination.	Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.	Randomization to one month post randomization
Secondary	Change in NTproBNP	Serologic blood work measured at randomization and post-randomization	Randomization to one month post randomization
Secondary	Change in high-sensitivity troponin	Serologic blood work measured at randomization and post-randomization	Randomization to one month post randomization
Secondary	Changes in inflammatory markers	Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization	Randomization to one month post randomization