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INVESTED: Flu Vaccine in Patients with Heart Disease - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn if an investigational high-dose flu vaccine is able to safely reduce heart- or lung-related problems compared to the standard-dose flu vaccine because getting the flu puts people at higher risk for heart problems.

What is the Condition Being Studied?

Flu vaccine in people with heart disease

Who Can Participate in the Study?

Adults:
- With a history of EITHER a heart attack in the past 12 months (1 year) OR a hospitalization for heart failure in the past 24 months (2 years)  
- With no known allergy or hypersensitivity to the flu vaccine  
- With no history of Guillain-Barre Syndrome (GBS) within 6 weeks after getting a flu vaccine  
- With no severe allergy to egg protein

For more information about who can participate in this study, please contact the study team.

Age Group
Adults

What is Involved?

If you choose to join this study, you will:

- Be randomized (like flipping a coin) to get a high dose or standard dose flu vaccine

- Have 1 in-person clinic visit for a flu vaccine at the start of the flu season (this visit will take about 90 minutes)

- Receive 3 telephone calls over the course of the flu season (about 10 minutes each) to see how you're tolerating the vaccine and how you're feeling.  

- Depending on the year you start in the study, you may have the initial visit, study flu vaccine, and telephone calls described above each year for up to 3 years.

Study Details

Full Title
Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated heart failure
Principal Investigator
Interventional Cardiologist
Protocol Number
IRB:PRO00085238
NCT:NCT02787044
Phase
Phase IV
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698