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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Division of Research
RECRUITING
Pleasanton
Contact Information
Primary
Alan S Go, MD
alan.s.go@kp.org
510-821-0904
Time Frame
Start Date: 2026-04-20
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 3000
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Kaiser Permanente
Collaborators: Garfield Memorial Fund

This content was sourced from clinicaltrials.gov

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