Timing of Influenza Vaccination in Patients With Heart Failure

Not Applicable

• Conditions: Heart Failure

• Registration Number: NCT05507502
• Lead Sponsor: Abhinav Sharma

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-11-23
• Status Verified: 2022-08
• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-16
• Last Update Submitted: 2022-08-16
• Study First Posted: 2022-08-19
• Last Update Posted: 2022-08-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Seroconversion for one or more strains in the influenza vaccine one month following vaccination.	Randomization to one month post randomization	Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.

Secondary Outcome Measures

Name	Time	Method
Change in NTproBNP	Randomization to one month post randomization	Serologic blood work measured at randomization and post-randomization
Change in high-sensitivity troponin	Randomization to one month post randomization	Serologic blood work measured at randomization and post-randomization
Changes in inflammatory markers	Randomization to one month post randomization	Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization

Trial Locations

Locations (1)

McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada