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

NCT07467668 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2026-03-12

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Garfield Memorial Fund

    collaborator OTHER

  • Kaiser Permanente

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-09
Primary Completion
2028-03-31
Completion
2028-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07467668 on ClinicalTrials.gov