Clinical trial NCT05507502: Timing of Influenza Vaccination in Patients With Heart Failure
Official title: Optimizing the Timing of Influenza Vaccination in Patients With Heart Failure: the FLU-HF Randomized Trial: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants 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.
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Seroconversion for one or more strains in the influenza vaccine one month following vaccination.
timeFrame: Randomization to one month post randomization
Secondary outcomes:
measure: Change in NTproBNP
timeFrame: Randomization to one month post randomization
measure: Change in high-sensitivity troponin
timeFrame: Randomization to one month post randomization
measure: Changes in inflammatory markers
timeFrame: Randomization to one month post randomization
Other outcomes:
measure: Seroconversion for one or more strains in the influenza vaccine upto three months following vaccination.
timeFrame: Randomization to three months post randomization
measure: Change in NTproBNP
timeFrame: Randomization to three months post randomization
measure: Change in high-sensitivity troponin
timeFrame: Randomization to three months post randomization
measure: Changes in inflammatory markers
timeFrame: Randomization to three months post randomization
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre
state: Quebec
Study officials:
References: