Ferric Derisomaltose for Heart Failure

(ICONIC-HF Trial)

Overseen By Pharmacosmos Clinical and non-clinical Department

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Pharmacosmos A/S

Must not be taking: IV iron, Chemotherapy

Disqualifiers: Planned cardiac surgery, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

1900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ferric derisomaltose, an iron supplement, to determine its effectiveness for people with chronic heart failure and low iron levels. Researchers aim to find out if this treatment can reduce hospital visits or deaths related to heart or blood vessel diseases. Participants will receive either the ferric derisomaltose treatment or no additional treatment while continuing their usual care. The trial seeks individuals who experience symptoms like fatigue or shortness of breath during physical activity due to heart failure and have a reduced heart pumping ability (45% or less). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, all participants will continue to receive standard care, which usually means you can keep taking your regular medications unless told otherwise by the trial team.

Is there any evidence suggesting that ferric derisomaltose is likely to be safe for humans?

A previous study found intravenous ferric derisomaltose to be safe and well tolerated, with only one likely reaction related to the infusion. Another study identified no major safety concerns during the follow-up period. Among 1,525 patients, including those with heart failure, the rate of serious or severe side effects was low. This evidence suggests that ferric derisomaltose is generally safe for patients. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for heart failure?

Ferric Derisomaltose is unique because it addresses iron deficiency in heart failure patients by providing intravenous iron that is tailored to a patient's weight and hemoglobin levels. Unlike traditional oral iron supplements, which can take weeks or months to improve iron levels and often come with gastrointestinal side effects, Ferric Derisomaltose has the potential to rapidly increase iron stores and improve symptoms. Researchers are excited about this treatment because it offers a quick and efficient way to address iron deficiency, potentially leading to better outcomes and quality of life for heart failure patients.

What evidence suggests that ferric derisomaltose might be an effective treatment for heart failure?

Studies have shown that ferric derisomaltose can benefit people with heart failure who lack sufficient iron. In this trial, some participants will receive ferric derisomaltose, which research indicates reduces hospital visits and deaths related to heart and blood vessel issues. The IRONMAN study found that patients receiving ferric derisomaltose had better outcomes compared to those who did not. Nearly half of the patients with heart failure and reduced heart function experience iron deficiency, highlighting the importance of iron supplementation. This treatment replenishes iron levels, which are crucial for heart health. ^{2 3 4 6 7}

Who Is on the Research Team?

Pharmacosmos Clinical and non-clinical department

Principal Investigator

Pharmacosmos A/S

Are You a Good Fit for This Trial?

This trial is for adults with chronic heart failure who feel tired or short of breath during physical activity, have a left ventricle ejection fraction of 45% or less, and are iron deficient. It's not suitable for those who don't meet these specific heart function and iron level criteria.

Inclusion Criteria

I am either a man or a woman.

I have low iron levels in my blood.

I experience symptoms like fatigue or shortness of breath during physical activity due to heart failure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either Ferric Derisomaltose or no treatment, with standard of care provided to all

12 weeks

4-5 visits (in-person), 7 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ferric Derisomaltose

Trial Overview The study tests if ferric derisomaltose (an IV Iron treatment) can reduce hospital admissions or death from heart-related diseases in people with chronic heart failure and iron deficiency. Half the participants will receive this treatment while the other half won't, but all get standard care.

How Is the Trial Designed?

Group I: Ferric Derisomaltose Experimental Treatment 1 Intervention

50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below \<25 %

Group II: Control Active Control 1 Intervention

50 % of the subjects will receive no IV iron

Who Is Running the Clinical Trial?

Pharmacosmos A/S

Lead Sponsor

Trials

45

Recruited

9,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9850675/

Ferric derisomaltose therapy and heart failure Nearly 50% of patients with heart failure with reduced ejection fraction (HFrEF) meet current criteria for iron deficiency, and there has been ...

2. heart.bmj.com heart.bmj.com/content/111/13/634

Age-stratified Effects of IV Ferric Derisomaltose in Heart Failure Intravenous iron therapy with ferric derisomaltose (FDI) has been shown to improve outcomes in patients with heart failure with reduced ejection fraction ( ...

3. thelancet.com thelancet.com/journals/lancet/article/piis0140-6736(22)02083-9/fulltext

Intravenous ferric derisomaltose for heart failure/iron deficiency Data from IRONMAN, showing improvements in outcomes in patients with heart failure and both reduced and mildly reduced ejection fraction ...

4. acc.org acc.org/Latest-in-Cardiology/Clinical-Trials/2022/11/04/14/19/ironman

Effectiveness of Intravenous Iron Treatment Versus ... Intravenous ferric derisomaltose in patients with heart failure and iron deficiency in the UK (IRONMAN): an investigator-initiated ...

5. medrxiv.org medrxiv.org/content/10.1101/2025.09.11.25335472v1

A Network Meta-Analysis of 15 Randomized Trials Results Twelve trials reported hospitalization for heart failure, showing significant reduction with ferric carboxymaltose (risk ratio 0.80 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06929806

NCT06929806 | Multi-center Trial of Ferric Derisomaltose ... ... derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. ... ferric derisomaltose to no treatment with ferric derisomaltose ...

7. ajconline.org ajconline.org/article/S0002-9149(21)00422-7/fulltext

Safety and Efficacy of Intravenous Ferric Derisomaltose ... Of 1,525 patients included in the safety analysis, 244 (16%) had a history of heart failure (HF). Overall, the rate of serious or severe ...