3000 Participants NeededMy employer runs this trial

Iron Infusion Notification for Heart Failure

(INITIATE-HF Trial)

AS
Overseen ByAlan S Go, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether reminders to doctors about iron deficiency treatment guidelines influence the use of IV iron (intravenous iron infusion) in hospitalized patients with heart failure. The study includes two groups: one where doctors receive notifications about their patient's iron levels and treatment recommendations, and another where doctors follow usual care without notifications. The goal is to determine if these reminders increase the use of IV iron and lead to better health outcomes, such as fewer hospital visits. The trial seeks adults with heart failure who have low iron levels and are currently hospitalized. As an unphased trial, it offers patients the chance to contribute to innovative research that could enhance treatment practices and outcomes for heart failure patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with your doctor to understand how your current medications might interact with the study.

What prior data suggests that this notification protocol is safe for use in heart failure patients?

Studies have shown that administering iron through an IV is generally safe for people with heart failure and low iron levels. Research has found that IV iron can lead to better long-term outcomes, such as fewer hospital visits for heart issues and a reduced risk of dying from heart problems. Simply put, it helps the heart function better and reduces hospitalizations.

Another study showed that most people tolerate IV iron well, experiencing no serious side effects. Experts recommend IV iron for people with heart failure who also have low iron, indicating it is both safe and effective for this group.

Overall, the evidence suggests that IV iron is a safe option for those with heart failure and low iron levels.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the impact of keeping physicians informed about their patients' iron deficiency in heart failure management. Unlike standard treatments that focus directly on prescribing medications, this approach aims to see if physician notifications can improve how patients receive iron infusions. By informing doctors about the latest guidelines and available IV iron formulations, the trial could lead to more personalized and timely care, potentially improving patient outcomes without introducing new drugs.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are hospitalized, have heart failure with reduced heart pumping ability (ejection fraction less than 50%), and show low iron levels. Participants must also have had health insurance and prescription coverage for at least six months before being admitted.

Inclusion Criteria

I am an adult with heart failure, low ejection fraction, and iron deficiency.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Intervention

Physicians of eligible patients in the intervention group receive a one-time notification about iron deficiency and guidelines for IV iron therapy

1 week
Notification sent to physicians

Treatment

Administration of IV iron during the index hospitalization for eligible patients

Up to 7 days

Follow-up

Participants are monitored for effectiveness outcomes, including all-cause death and heart failure-related hospitalization

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • No Notification Group
  • Notification Group

Trial Overview

The study tests if reminding doctors about iron deficiency treatment guidelines increases the use of IV iron in patients with heart failure and low iron. Doctors either get a notification about their patient's test results or no extra information; patient care is then compared between these groups.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Intervention Medical Center - Notification GroupActive Control1 Intervention
Group II: Control Medical Center - No Notification GroupActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kaiser Permanente

Lead Sponsor

Trials
563
Recruited
27,400,000+

Garfield Memorial Fund

Collaborator

Trials
5
Recruited
1,900+

Citations

Intravenous Iron Therapy in Patients Admitted With Acute ...

The role of intravenous (IV) iron in chronic heart failure (HF) has been well studied, becoming a class IA recommendation.

Efficacy and safety of intravenous iron repletion in patients ...

Use of FCM/FDI is safe and reduces the composite of recurrent HF hospitalizations and CVD, while effects on CVD alone are based on available level of data ...

Intravenous Iron Repletion for Patients With Heart Failure ...

Iron deficiency and heart failure frequently occur concurrently and are associated with adverse cardiovascular outcomes. •. Early trials of intravenous iron ...

Treatment With IV Iron in Hospitalized Patients With Severe ...

The study will test for the effects of the additional IV iron on the symptoms, clinical picture and quality of life of the treated patients. Detailed ...

Intravenous iron improved long-term outcomes for people ...

Repeated intravenous (IV) administration of iron reduced the risk of hospitalization for heart failure and cardiovascular death in people with ...