Recruiting

Influenza Vaccination

Sponsor:

Abhinav Sharma

Code:

NCT05507502

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Influenza vaccination administration

Study Details

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.

Conditions

Heart Failure

Study ID

NCT05507502

Start date

Nov 23, 2021

Status verified date

Aug, 2022

Completion date

Jun 30, 2024

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: In-patient vaccination arm

Participants in this arm will receive the influenza vaccination during their heart failure hospitalization.

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.

Interventions

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.

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 ]

Central Contacts and Locations

Central contacts

Locations

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

More Information

Sponsor

Abhinav Sharma

Last update posted

Aug 19, 2022

Last verified

Aug, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Abhinav Sharma on 2022-08-19.