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

NCT07467668 | Not Yet Recruiting

• 1 other identifier: 2090665
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Keywords

IV iron; iron deficiency; heart failure

Outcome Measures

Primary Outcomes (1)

• % of patients receiving IV iron within 7 days of hospital admission

  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.

  From the day of confirmed eligibility up to 7 days later

Secondary Outcomes (1)

• % of patients who experience the composite outcome of all-cause death and heart failure-related hospitalization

  From randomization to the end of 12 months after randomization

Study Arms (2)

Intervention Medical Center - Notification Group

ACTIVE COMPARATOR

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.

Other: Notification Group

Control Medical Center - No Notification Group

ACTIVE COMPARATOR

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.

Other: No Notification Group

Interventions

Notification Group OTHER

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.

Intervention Medical Center - Notification Group

No Notification Group OTHER

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).

Control Medical Center - No Notification Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Kaiser Permanente: lead
• Garfield Memorial Fund: collaborator

Study Sites (1)

Division of Research

Pleasanton, California, 94588, United States

Location

MeSH Terms

Conditions

Iron Deficiencies; Heart Failure; Heart Failure, Systolic

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Alan S Go, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Division of Research

Model Details: The INITIATE-HF study is a cluster randomized controlled trial randomized at the medical center level. Participating medical centers will be randomly divided into two groups, with balanced populations between the groups based on demographic and heart failure-related characteristics. In medical centers assigned to the intervention group, physicians of eligible patients with HF and iron deficiency (i.e., TSAT \<20%) will be sent information from current KPNC and national clinical practice guidelines about use of IV iron therapy. In medical centers assigned to the control group, physicians will not receive information about their patients or about current guidelines about the use of IV iron (i.e., usual care).

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 12, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Requests for IPD will be considered starting 6 months after publication of the primary results of the study, with an end date of 10 years after study closure. Supporting information will be available as of 09 MAR 2026, with no end date.
• Access Criteria: De-identified individual participant data underlying the results of this trial will be considered for sharing with qualified researchers. Requests must include a scientifically sound proposal and documentation of IRB approval or exemption. Data access will be subject to review and execution of an appropriate data use agreement to protect participant privacy. There will be no restriction to access supporting information.

Locations

US (1)