VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT) (NCT02268500) | Clinical Trial Compass
CompletedPhase 4
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
United States48 participantsStarted 2014-09
Plain-language 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 high dose influenza vaccine. Post-vaccine antibody measurements will be assessed, as well as tolerability differences between groups.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H1N1 Vaccine Antigens
Timeframe: 4 weeks
2
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of A/H3N2 Vaccine Antigens
Timeframe: 4 weeks
3
Number of Participants With 4 Fold Rise in Serum Antibody Concentration of B-type Vaccine Antigens
. 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