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Study on Ferric Derisomaltose for Patients with Iron Deficiency and Chronic Heart Failure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for people with Chronic Heart Failure who also have low iron levels, a condition known as iron deficiency. The treatment being tested is called ferric derisomaltose, which is a type of iron given through an injection into a vein. The study will compare the effects of this iron treatment to not receiving any intravenous iron.

The purpose of the study is to see if ferric derisomaltose can help reduce the number of deaths related to heart problems and the number of times patients need to be hospitalized due to worsening heart failure. Participants in the study will be randomly assigned to receive either the iron treatment or no iron treatment. The study will monitor participants over a period of time to track their health outcomes, such as hospital visits and overall survival.

Throughout the study, researchers will collect information on various health indicators, including changes in heart failure symptoms and iron levels in the blood. The study aims to provide valuable insights into whether treating iron deficiency with ferric derisomaltose can improve the health and quality of life for people with Chronic Heart Failure.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, participants will be randomly assigned to one of two groups. One group will receive the medication ferric derisomaltose, while the other group will not receive any intravenous iron treatment.

    Participants will be informed about the study procedures and will be required to sign an informed consent form to confirm their willingness to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to evaluate their health status. This includes checking vital signs and conducting laboratory tests to measure levels of hemoglobin, ferritin, and other relevant markers.

    The assessment will help determine the participant's baseline health condition before starting the treatment.

  3. Step 3

    Treatment administration

    Participants in the treatment group will receive ferric derisomaltose through an intravenous infusion. The dosage and frequency will be determined by the study protocol and the participant's specific health needs.

    The duration of the treatment will be specified in the study protocol, and participants will be monitored for any immediate reactions during and after the infusion.

  4. Step 4

    Regular follow-up visits

    Participants will attend regular follow-up visits to monitor their health and the effects of the treatment. These visits will include physical examinations, laboratory tests, and assessments of heart function.

    The frequency of these visits will be outlined in the study protocol, and participants will be informed of the schedule in advance.

  5. Step 5

    Monitoring and reporting

    Throughout the study, participants will be asked to report any side effects or changes in their health. This information is crucial for assessing the safety and effectiveness of the treatment.

    Participants will also be monitored for any hospitalizations or changes in their heart failure symptoms.

  6. Step 6

    Final assessment

    At the end of the study period, participants will undergo a final assessment to evaluate the overall impact of the treatment on their health.

    This assessment will include a review of all collected data, including laboratory results and any reported side effects or hospitalizations.

Who can join the trial?

13 criteria

  • Must be at least 18 years old.
  • Have a Left Ventricular Ejection Fraction (LVEF) of 45% or less. This is a measure of how well the heart is pumping blood.
  • Have a history of heart failure and be classified as NYHA class II, III, or IV. This is a way to describe the severity of heart failure symptoms.
  • Have a hemoglobin (Hb) level between 9 and 13 g/dL for women, and between 9 and 14 g/dL for men. Hemoglobin is a protein in red blood cells that carries oxygen.
  • Have a Transferrin Saturation (TSAT) of less than 20%. This is a measure of iron in the blood.
  • Be on the maximum tolerated medical therapy for heart failure as determined by the study doctor. This means taking the most effective medication dose that you can handle.
  • Show evidence of being in a higher risk heart failure group, such as:
    • Currently hospitalized for worsening heart failure but stable and expected to be discharged.
    • Identified in outpatient services or emergency departments with elevated natriuretic peptides. These are substances released by the heart when it is under stress.
    • Meet at least one of the following prognostic enrichment criteria:
      • Medical history of ischemic heart failure, prior heart attack, or prior coronary revascularization.
      • Estimated Glomerular Filtration Rate (eGFR) of 45 mL/min/1.73 m² or less. This is a measure of kidney function.
      • TSAT of 15% or less.
      • Anemia, defined as a hemoglobin level of 9 to less than 12 g/dL for women, and 9 to less than 13 g/dL for men.
      • Willing to participate and sign the Informed Consent Form (ICF).

Who cannot join the trial?

6 criteria

  • Patients who do not have Chronic Heart Failure cannot participate.
  • Patients who are not iron-deficient cannot participate. Iron deficiency means having lower than normal levels of iron in the body.
  • Patients who are not experiencing symptoms of Chronic Heart Failure cannot participate. Symptoms are signs or feelings of illness.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are not willing to follow the study procedures cannot participate.
  • Patients who are part of a vulnerable population may not be eligible. Vulnerable populations include groups who may need special protection or care.
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Investigated drugs

Ferric Derisomaltose is a type of iron given through an IV, which means it is delivered directly into your bloodstream. This medication is used to help people who have low iron levels, a condition known as iron deficiency. In this trial, it is being tested to see if it can help people with chronic heart failure, a condition where the heart doesn't pump blood as well as it should. The goal is to see if this iron treatment can reduce the risk of death from heart problems and lower the number of times patients need to go to the hospital because their heart failure symptoms get worse.

What is already known about the treatment

Ferric Derisomaltose – Ferric derisomaltose is administered intravenously, meaning it is given directly into a vein through an injection. It is currently being studied in clinical trials for its effectiveness in treating iron deficiency in patients with chronic heart failure. The main therapeutic use of ferric derisomaltose is to improve symptoms and reduce hospitalizations related to heart failure by addressing iron deficiency. At the molecular level, it works by replenishing iron stores in the body, which is essential for producing healthy red blood cells and improving oxygen transport. It is classified as an iron replacement therapy.

Investigated diseases

Chronic Heart Failure – Chronic Heart Failure is a condition where the heart is unable to pump blood effectively to meet the body's needs. Over time, the heart's ability to function diminishes, leading to symptoms such as fatigue, shortness of breath, and fluid retention. The condition progresses as the heart muscle weakens or becomes stiff, affecting its ability to fill and pump blood. This can result in the enlargement of the heart chambers and increased pressure in the heart. As the disease advances, individuals may experience worsening symptoms and reduced physical activity tolerance. The progression of Chronic Heart Failure can lead to frequent hospitalizations due to exacerbations of symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519059-28-00Protocol codeP-Monofer-CHF-02Estimated enrolment1 759 patientsSponsorPharmacosmos A/S

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