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Vaccine

Influenza Vaccine Timing for Heart Failure (FLU-HF Trial)

N/A

Recruiting

Research Sponsored by Abhinav Sharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admitted in hospital with primary diagnosis of acute HF

Age > 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up randomization to one month post randomization

Awards & highlights

FLU-HF Trial Summary

This 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.

Who is the study for?

This trial is for adults over 18 who have been hospitalized with acute heart failure but are stable without intensive treatments like inotropes or IV diuretics for at least a day. They must have had chronic heart failure for more than three months, be able to visit the clinic as scheduled, and agree to get a flu shot. It's not for those already vaccinated this season, in another study, with an allergy to the vaccine, undergoing cancer treatment, unlikely to survive until discharge or post-organ transplant.Check my eligibility

What is being tested?

The FLU-HF trial is testing whether it's better to give the flu vaccine to patients when they're admitted with acute heart failure or after they've stabilized and left the hospital. The goal is to see which timing leads to a stronger immune response against influenza.See study design

What are the potential side effects?

While side effects of the influenza vaccination can vary from person-to-person, common reactions include soreness at injection site, mild fever, muscle pains and feeling tired. Severe allergic reactions are rare.

FLU-HF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am hospitalized with a primary diagnosis of acute heart failure.

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I am older than 18 years.

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I agree to get the flu shot.

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I haven't used heart pumps, IV fluids for swelling, or support machines in the last day.

FLU-HF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ randomization to three months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~randomization to three months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization to three months post randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Seroconversion for one or more strains in the influenza vaccine one month following vaccination.

Other outcome measures

Change in NTproBNP

Change in high-sensitivity troponin

Changes in inflammatory markers

+1 more

FLU-HF Trial Design

2Treatment groups

Active Control

Group I: In-clinic vaccination armActive Control1 Intervention

Participants in this arm will receive the influenza vaccination during their follow up visit in the heart failure clinic 30 days post-discharge.

Group II: In-patient vaccination armActive Control1 Intervention

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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abhinav SharmaLead Sponsor

Media Library

Influenza vaccination administration (Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05507502 — N/A

Heart Failure Research Study Groups: In-clinic vaccination arm, In-patient vaccination arm

Heart Failure Clinical Trial 2023: Influenza vaccination administration Highlights & Side Effects. Trial Name: NCT05507502 — N/A

Influenza vaccination administration (Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05507502 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any ongoing opportunities to participate in this trial?

"According to the clinicaltrials.gov website, this research is actively searching for participants; it was initially listed on November 23rd 2021 and most recently updated on August 16th 2022."

Answered by AI

How many people are participating in this experiment?

"Affirmative. According to clinicaltrials.gov, the trial which opened on November 23rd 2021 is still accepting patients for participation. The listing was last edited in August of this year and 40 individuals need to be enrolled from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Timing of Influenza Vaccination in Patients With Heart Failure

Abhinav Sharma 2021. "Timing of Influenza Vaccination in Patients With Heart Failure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05507502.

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