NCT07467668 · Kaiser Permanente
Infusing Needed Iron to Target Insufficiency in Adults Treated for Evidence of Heart Failure
(INITIATE-HF)
What this study is about
The INITIATE-HF study is a cluster randomly assigned 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 given through a vein (IV) (IV) iron.
View original scientific description
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.
Interventions
OTHER
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.
OTHER
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).
Primary outcome measures
% of patients receiving IV iron within 7 days of hospital admission
Time frame: From the day of confirmed eligibility up to 7 days later
The primary outcome is the implementation outcome of the percentage of patients who receive IV iron within 7 days of hospitalization to determine how the provider-facing notification influences provider behavior and care processes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pleasanton, California
Collaborators
Garfield Memorial Fund
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Frequently asked questions
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Data: ClinicalTrials.gov · synced Aug 5, 2026 · Source of record for eligibility and locations