Timing of Influenza Vaccination in Patients With Heart Failure

NCT05507502 | Unknown

• 1 other identifier: 2021-7425
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Randomization to one month post randomization

Secondary Outcomes (3)

• Change in NTproBNP

  Randomization to one month post randomization

• Change in high-sensitivity troponin

  Randomization to one month post randomization

• Changes in inflammatory markers

  Randomization to one month post randomization

Other Outcomes (4)

• Seroconversion for one or more strains in the influenza vaccine upto three months following vaccination.

  Randomization to three months post randomization

• Change in NTproBNP

  Randomization to three months post randomization

• Change in high-sensitivity troponin

  Randomization to three months post randomization

Study Arms (2)

In-patient vaccination arm

ACTIVE COMPARATOR

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

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.

Biological: Influenza vaccination administration

Interventions

Influenza vaccination administration 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; In-patient vaccination arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abhinav Sharma: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Dina Moawad, MSc.

CONTACT

(514) 934-1934; dina.moawad@muhc.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Division of Cardiology

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2022
• First Posted: August 19, 2022
• Study Start: November 23, 2021
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: August 19, 2022

Record last verified: 2022-08

Locations

CA (1)