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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Similarly, mixed effects Poisson regression will be additionally performed to analyze the effect of the intervention in relation to secondary outcomes when characterized as counts: all-cause and heart failure-specific outpatient encounters (i.e., clinic and telehealth visits), emergency department visits, and hospitalizations."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether reminders to doctors lead to more use of IV iron, which is iron given through a vein. It is for adults in the hospital who have heart failure, low iron, and a heart pumping level below 50%. Doctors who get reminders will be compared with doctors who provide usual care without reminders.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are older than 18.
  • You have heart failure, and your latest test shows your heart's main pumping chamber pumps out less than 50% of its blood with each beat.
  • You are in the hospital for any reason.
  • A blood test during this hospital stay shows low iron: transferrin saturation (TSAT) below 20%.
  • You had health plan coverage and prescription drug benefits for at least 6 months before admission.

Who can't join

  • Your Kaiser Permanente Northern California health record lists an allergy to IV iron.
  • You have a history of hemochromatosis, a condition that causes too much iron in the body.
  • You receive ongoing dialysis, a treatment that filters blood, or have had a kidney transplant.
  • You have advanced long-term kidney disease, with a kidney filtering test (eGFR) below 30.
  • Your ferritin level, a blood test of stored iron, is above 300 ng/mL.
  • You have cancer that has spread to other parts of the body or receive chemotherapy that treats the whole body.
  • You live in an institution, such as a prison, or receive palliative care, which focuses on relief from symptoms.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

CA