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Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure
Sponsor: Kaiser Permanente
Summary
The INITIATE-HF study is a cluster randomized controlled trial that aims to find out if reminding doctors about treatment guidelines for iron deficiency in adults with heart failure who are hospitalized and have evidence of iron deficiency changes the subsequent use of intravenous (IV) iron. Two groups of hospitalized adult patients with known heart failure and iron deficiency will be compared: * Group 1 will include doctors who receive a notification with their patient's iron storage test results and guideline recommendations related to the use of IV iron. * Group 2 will include doctors who do not receive this notification and continue with usual standard of care. The study will measure if this provider-facing notification affects physician use of recommended IV iron treatment in eligible patients with heart failure, left ventricular ejection fraction less than 50%, and iron deficiency. Secondarily, if there is an increased use of IV iron observed in the intervention group, this study will evaluate whether there are differential health outcomes (i.e., fewer subsequent hospital visits and lower risk of death) of patients whose providers were assigned to the intervention group.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
3000
Start Date
2026-03-09
Completion Date
2028-12-31
Last Updated
2026-03-12
Healthy Volunteers
No
Conditions
Interventions
Notification Group
In medical centers assigned to the intervention group within the INITIATE-HF study, physicians of eligible patients with HF and iron deficiency will be sent information from current KPNC and national guidelines about IV iron therapy.
No Notification Group
In medical centers assigned to the control group, physicians will not receive information about current guidelines about the use of IV iron (i.e., usual care).
Locations (1)
Division of Research
Pleasanton, California, United States