In-patient vaccination arm for Heart Failure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
McGill University Health Centre, Montreal, Canada
Heart Failure
Influenza vaccination administration - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: Randomization to three months post randomization

Randomization to one month post randomization
Seroconversion for one or more strains in the influenza vaccine one month following vaccination.
Randomization to three months post randomization
Change in NTproBNP
Change in high-sensitivity troponin
Changes in inflammatory markers
Seroconversion for one or more strains in the influenza vaccine upto three months following vaccination.

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

In-patient vaccination arm
1 of 2
In-clinic vaccination arm
1 of 2
Active Control

40 Total Participants · 2 Treatment Groups

Primary Treatment: In-patient vaccination arm · No Placebo Group · N/A

In-patient vaccination arm
Biological
ActiveComparator Group · 1 Intervention: Influenza vaccination administration · Intervention Types: Biological
In-clinic vaccination arm
Biological
ActiveComparator Group · 1 Intervention: Influenza vaccination administration · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: randomization to three months post randomization
Closest Location: McGill University Health Centre · Montreal, Canada
Photo of montreal 1Photo of montreal 2Photo of montreal 3
2004First Recorded Clinical Trial
8 TrialsResearching Heart Failure
127 CompletedClinical Trials

Who is running the clinical trial?

Abhinav SharmaLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have been admitted to hospital with a primary diagnosis of acute heart failure.
You are not on inotropes, mechanical support, or IV diuretics for 24 hours.
You are able to follow-up within the MUHC HF clinic as per schedule.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.