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

Conditions

• Heart Failure
• Heart Failure and Mildly Reduced Ejection Fraction
• Heart Failure and Reduced Ejection Fraction
• Iron Deficiency (ID)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.
• 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).

Study Details

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.

Key Dates

Start date

Mar 9, 2026

Status verified

Feb 2026

Primary completion

Mar 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

3,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

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.

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

• Alan S Go, MD
  510-821-0904
  [email protected]

Locations (1)

Find similar trials in Pleasanton, CA

Related Studies

• Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
  Recruiting · Medtronic · Birmingham, Alabama
• The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
  Recruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona
• Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients
  PHASE2 · Recruiting · Baylor Research Institute · Los Angeles, California
• Metformin for Pulmonary Hypertension HFpEF
  PHASE2 · Recruiting · University of California, San Francisco · San Francisco, California