Recruiting

IV Iron

Sponsor:

Kaiser Permanente

Code:

NCT07467668

Conditions

Iron Deficiency (ID)

Heart Failure

Heart Failure and Reduced Ejection Fraction

Heart Failure and Mildly Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Notification Group

No Notification Group

Study Details

Brief 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.

Conditions

Iron Deficiency (ID)

Heart Failure

Heart Failure and Reduced Ejection Fraction

Heart Failure and Mildly Reduced Ejection Fraction

Study ID

NCT07467668

Start date

Apr 20, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Intervention Medical Center - Notification Group

In medical centers assigned to the intervention group, physicians of eligible patients will be sent a one-time notification with information about their patient's iron deficiency, current KPNC and national clinical practice guidelines about IV iron therapy, and available IV iron formulations and recommended dosages.

active comparator: Control Medical Center - No Notification Group

In medical centers assigned to the control group, physicians of eligible patients will NOT be sent information about their patients or current KPNC and national clinical practice guidelines about the use of IV iron therapy in the setting of heart failure.

Interventions

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.

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 measure

  • % of patients receiving IV iron within 7 days of hospital admission [ Time Frame: From the day of confirmed eligibility up to 7 days later ]

Central Contacts and Locations

Central contacts

Alan S Go, MD

510-821-0904alan.s.go@kp.org

Locations

Division of Research

Recruiting

Pleasanton, California, United States, 94588

Contacts

Elisha A Garcia, BS

415--579-5301elisha.a.garcia@kp.org

More Information

Sponsor

Kaiser Permanente

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • IV iron
  • iron deficiency
  • heart failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kaiser Permanente on 2026-08-05.