Heart FailureFLU-HFNCT05507502
Timing of Influenza Vaccination in Patients With Heart Failure
A study testing Influenza vaccination administration in people with Heart Failure, run by Abhinav Sharma at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Influenza vaccination administration
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2021to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Abhinav Sharma, 514934193432903, abhinav.sharma@mcgill.ca
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Influenza vaccination administration
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccination administrationBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| In-patient vaccination arm | Active comparator | Participants in this arm will receive the influenza vaccination during their heart failure hospitalization. Receives: Biological: Influenza vaccination administration |
| In-clinic vaccination arm | Active comparator | Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge. Receives: Biological: Influenza vaccination administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Randomization to one month post randomization
Secondary outcomes (3)
Change in NTproBNP
Serologic blood work measured at randomization and post-randomization
Measured: Randomization to one month post randomization
Change in high-sensitivity troponin
Serologic blood work measured at randomization and post-randomization
Measured: Randomization to one month post randomization
Changes in inflammatory markers
Inflammatory markers as measured by HsCRP, IL1, IL6, at randomization and post-randomization
Measured: Randomization to one month post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start23 Nov 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abhinav Sharma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Abhinav Sharma, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507502
- Sponsor's protocol ID
- 2021-7425
- Acronym
- FLU-HF
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Timing of Influenza Vaccination in Patients With Heart Failure: the FLU-HF Randomized Trial: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05507502
- Acronym / sponsor ID
- FLU-HF / 2021-7425
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Abhinav SharmaUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 19 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| In-patient vaccination arm | Active comparator | Biological: Influenza vaccination administrationParticipants in this arm will receive the influenza vaccination during their heart failure hospitalization. |
| In-clinic vaccination arm | Active comparator | Biological: Influenza vaccination administrationParticipants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccination administrationThere 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. | Biological | In-clinic vaccination arm, In-patient vaccination arm |
Primary outcome
Seroconversion for one or more strains in the influenza vaccine one month following vaccination.
Time frame: Randomization to one month post randomization
Seroconversion will be measured by antibody as assessed by the hemagglutination inhibition (HI) assay.
3 secondary outcomes
Change in NTproBNP
Time frame: Randomization to one month post randomization
Change in high-sensitivity troponin
Time frame: Randomization to one month post randomization
Changes in inflammatory markers
Time frame: Randomization to one month post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccination administration in people with Heart Failure, run by Abhinav Sharma at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dina Moawad, MSc. ((514) 934-1934 ext. 35414, dina.moawad@muhc.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion for one or more strains in the influenza vaccine one month following vaccination. (time frame: Randomization to one month post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.