Status:
COMPLETED
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20 patients to hi...
Detailed Description
This is a randomized, double blind, active-control trial of high dose influenza vaccine compared to standard dose influenza vaccine for one season in adult participants with symptomatic heart failure(...
Eligibility Criteria
Inclusion
- Adults \> 18 years old
- Able to give informed consent
- Systolic or diastolic dysfunction
- Previously or currently symptomatic heart failure
- Stable on current heart failure drug therapy regimen for \> 30 days and no change in heart failure drug therapy regimen on day of enrollment
- Hospitalization (for any reason) in last 12 months
- Received influenza vaccination the prior season
Exclusion
- History of allergic reaction or adverse event to influenza vaccine
- Documented severe allergy to egg products
- Unwilling or unable to give consent
- Moderate to severe acute febrile illness at baseline
- Immunologic conditions that may affect immune responses per clinical judgment of the investigators
- Use of immunosuppressants or immunomodulating therapies within 3 months of the study, including prednisone, cyclosporine, tacrolimus, methotrexate, azathioprine, mycophenolate mofetil, cyclophosphamide, and injectable interferons
- Participation in a clinical trial within 30 days
- Absence for more than 7 consecutive days during the surveillance period
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02268500
Start Date
September 1 2014
End Date
May 1 2016
Last Update
June 9 2021
Active Locations (1)
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1
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792