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Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: Adults (age \>18 years); Diagnosed heart failure with most recent left ventricular ejection fraction \<50%; Hospitalized for any reason for the index admission; Documented iron deficiency defined as TSAT \<20% during the index hospitalization; At least 6 months of health plan coverage and prescription drug benefit before admission Exclusion Criteria: A documented allergy to IV iron in the Kaiser Permanente Northern California (KPNC) electronic health record (EHR) system; A history of hemochromatosis (i.e., iron overload) based on KPNC EHR data; End-stage kidney disease (defined as receiving chronic dialysis or a prior kidney transplant) or advanced chronic kidney disease (i.e., estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m2) based on most recent pre-admission outpatient laboratory results or the KPNC regional End-Stage Kidney Disease Treatment Registry; Serum ferritin \>300 ng/mL based on KPNC EHR data; Diagnosed with metastatic cancer and/or receiving systemic chemotherapy based on KPNC EHR data; Institutionalized (e.g., prison) and/or receiving palliative care per KPNC EHR data
About the study
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.
What is being tested
- Notification Group (other)
- No Notification Group (other)
Sponsor: Kaiser Permanente · Participants: 3,000 · Started: Apr 20, 2026
Contact the study team
- Alan S Go, MD · Phone: 510-821-0904
Official record on ClinicalTrials.gov — NCT07467668
Locations in the U.S.
| California | Division of Research, Pleasanton |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.