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

Recruiting now · Not applicable

Conditions studied: Iron Deficiency (ID), Heart Failure, Heart Failure and Reduced Ejection Fraction, Heart Failure and Mildly Reduced Ejection Fraction

In brief

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 facts

Study ID

NCT07467668

Run by

Kaiser Permanente

People needed

3000

Starts

2026-04-20

Expected to finish

2028-12-31

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Division of Research — Pleasanton, California, United States (enrolling)

Full record on ClinicalTrials.gov

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