Timing of Influenza Vaccination in Patients With Heart Failure (FLU-HF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Biological: Influenza vaccination administration

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dina Moawad, MSc.; Phone Number: 35414 (514) 934-1934; Email: dina.moawad@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • Recruiting
      • McGill University Health Centre
      • Contact: Abhinav Sharma; Phone Number: 514934193432903; Email: abhinav.sharma@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: In-patient vaccination arm; Participants in this arm will receive the influenza vaccination during their heart failure hospitalization.	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.
ACTIVE_COMPARATOR: In-clinic vaccination arm; Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in NTproBNP	Serologic blood work measured at randomization and post-randomization	Randomization to three months post randomization
Change in high-sensitivity troponin	Serologic blood work measured at randomization and post-randomization	Randomization to three months post randomization
Changes in inflammatory markers	Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization	Randomization to three months post randomization

Collaborators and Investigators

• Sponsor: Abhinav Sharma

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2021
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): June 30, 2024

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 16, 2022
• First Posted (ACTUAL): August 19, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 16, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2021-7425

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No