Timing of Influenza Vaccination in Patients With Heart Failure (FLU-HF)
Primary Purpose
Heart Failure
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Influenza vaccination administration
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
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
Sites / Locations
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
In-patient vaccination arm
In-clinic vaccination arm
Arm Description
Participants in this arm will receive the influenza vaccination during their heart failure hospitalization.
Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in NTproBNP
Serologic blood work measured at randomization and post-randomization
Change in high-sensitivity troponin
Serologic blood work measured at randomization and post-randomization
Changes in inflammatory markers
Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05507502
Brief Title
Timing of Influenza Vaccination in Patients With Heart Failure
Acronym
FLU-HF
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 23, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Abhinav Sharma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
In-patient vaccination arm
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive the influenza vaccination during their heart failure hospitalization.
Arm Title
In-clinic vaccination arm
Arm Type
Active Comparator
Arm Description
Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge.
Intervention Type
Biological
Intervention Name(s)
Influenza vaccination administration
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seroconversion for one or more strains in the influenza vaccine one month following vaccination.
Description
Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.
Time Frame
Randomization to one month post randomization
Secondary Outcome Measure Information:
Title
Change in NTproBNP
Description
Serologic blood work measured at randomization and post-randomization
Time Frame
Randomization to one month post randomization
Title
Change in high-sensitivity troponin
Description
Serologic blood work measured at randomization and post-randomization
Time Frame
Randomization to one month post randomization
Title
Changes in inflammatory markers
Description
Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization
Time Frame
Randomization to one month post randomization
Other Pre-specified Outcome Measures:
Title
Seroconversion for one or more strains in the influenza vaccine upto three months following vaccination.
Description
Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.
Time Frame
Randomization to three months post randomization
Title
Change in NTproBNP
Description
Serologic blood work measured at randomization and post-randomization
Time Frame
Randomization to three months post randomization
Title
Change in high-sensitivity troponin
Description
Serologic blood work measured at randomization and post-randomization
Time Frame
Randomization to three months post randomization
Title
Changes in inflammatory markers
Description
Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization
Time Frame
Randomization to three months post randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dina Moawad, MSc.
Phone
(514) 934-1934
Ext
35414
Email
dina.moawad@muhc.mcgill.ca
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abhinav Sharma
Phone
514934193432903
Email
abhinav.sharma@mcgill.ca
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Timing of Influenza Vaccination in Patients With Heart Failure
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