Clinical Trial

Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure

Study acronym: INITIATE-HF
Recruiting
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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.
Protocol Amendment History 2 changes
critical Recruitment opened 2026-08-06
notable Primary completion moved earlier: 2028-03-31 -> 2027-12 2026-08-06
Trial Details
NCT Number NCT07467668
Lead Sponsor Kaiser Permanente
Collaborators: Garfield Memorial Fund
Conditions Iron Deficiency (ID), Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction
Enrollment 3,000 participants
Start Date 2026-04-20
Primary Completion 2027-12 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-05