Timing of Influenza Vaccination in Patients With Heart Failure

NCT ID: NCT05507502

Last Updated: 2022-08-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-23
• Study Completion Date: 2024-06-30

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

In-patient vaccination arm

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

Group Type: ACTIVE_COMPARATOR

Influenza vaccination administration

Intervention Type: BIOLOGICAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Influenza vaccination administration

Intervention Type: BIOLOGICAL

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.

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.

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abhinav Sharma

OTHER

Sponsor Role: lead

Responsible Party

Abhinav Sharma

Assistant Professor, Division of Cardiology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

McGill University Health Centre

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Dina Moawad, MSc.

Role: CONTACT

dina.moawad@muhc.mcgill.ca

(514) 934-1934 ext. 35414

Facility Contacts

Abhinav Sharma

Role: primary

abhinav.sharma@mcgill.ca

514934193432903

Other Identifiers

2021-7425

Identifier Type: -

Identifier Source: org_study_id