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

Study acronym: INITIATE-HF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Enrollment reduced 87% 3000 → 400 participants
See other at-risk trials from Kaiser Permanente

Record History

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  1. Notable Enrollment reduced: 3000 → 400 participants
    • Eligibility criteria shortened, about 22 words
    • Study description shortened, about 27 words
  2. Notable Recruitment opened
    • Primary completion moved earlier from Mar 31, 2028 to Dec 2027
    • Start date changed from estimate of Mar 9, 2026 to Apr 20, 2026
    • Site details revised
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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.
Trial Details
NCT Number NCT07467668
Lead Sponsor Kaiser Permanente
Collaborators: Garfield Memorial Fund
Conditions
(from sponsor)
Iron Deficiency (ID), Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction
Related terms Heart Failure, Heart Failure, Systolic, Iron Deficiencies
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov