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NCT Number: NCT06929806

Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

The goal of this clinical trial is to learn if the IV Iron treatment ferric derisomaltose helps in the treatment of chronic heart failure in people with iron deficiency. The main question it aims to answer is:

• How many participants are admitted to the hospital or die from a disease in the heart or blood vessels

Researchers will compare treatment with ferric derisomaltose to no treatment with ferric derisomaltose. This will be done to see how well ferric derisomaltose works.

Participants will:

* Be randomized 50/50 to either treatment with Ferric derisomaltose or to no treatment with ferric derisomaltose * All participants receives standard of care * Visit site 4-5 times and have 7 video/phone-calls

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Key information

Conditions

Chronic Heart Failure Iron Deficiencies Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Private clinic

Pasadena, California, 91105, United States

Location status: Recruiting

Location contact

MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • Both women and men can join
  • Heart failure that causes fatigue, shortness of breath, or other symptoms during physical activity
  • Have left ventricle (chamber) ejection fraction (pumping ability) that is 45% or less
  • Have low iron levels in the blood
  • New York Heart Association (NYHA) Heart Failure Classification II, III or IV

Exclusion criteria

  • Planned cardiac surgery or revascularization or cardiac device implantation
  • Pregnant or nursing women
  • Treatment with iron Intravenous (through the vein) or intramuscular (injection in the muscle) within the past 6 months
  • Treatment with radiotherapy or chemotherapy

Treatment and study plan

Ferric derisomaltose

Drug

100 mg/mL

Primary outcomes

  1. Number of cardiovascular deaths and hospitalizations for worsening heart failure

    Time frame: From enrollment to the end of follow-up at 52 weeks

Secondary outcomes

  1. Number of hospitalizations for worsening heart failure

    Time frame: From enrollment and no longer than end of follow-up at 52 weeks

  2. Time to cardiovascular death

    Time frame: From enrollment to the end of follow-up at 52 weeks

  3. Number of all-cause hospitalizations

    Time frame: From enrollment to the end of follow-up at 52 weeks

  4. Time to all-cause death

    Time frame: From enrollment to the end of follow-up at 52 weeks

  5. Time to first hospitalization for worsening heart failure or cardiovascular death

    Time frame: From enrollment to the end of follow-up at 52 weeks

  6. Number of hospitalizations for cardiovascular, respiratory, or renal disease

    Time frame: From enrollment to the end of follow-up at 52 weeks

  7. Time to cardiovascular, respiratory, or renal death

    Time frame: From enrollment to the end of follow-up at 52 weeks

  8. Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure

    Time frame: From enrollment to the end of follow-up at 52 weeks

  9. Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure

    Time frame: From enrollment to the end of follow-up at 52 weeks

  10. Time to all-cause death or first hospitalization

    Time frame: From enrollment to the end of follow-up at 52 weeks

  11. Days hospitalized or dead for cardiovascular reasons at week 52

    Time frame: From enrollment to the end of follow-up at 52 weeks

  12. Days hospitalized or dead for any reason at week 52

    Time frame: From enrollment to the end of follow-up at 52 weeks

  13. Change in NYHA from baseline to weeks 12, 26 and 52

    Time frame: From enrollment to weeks 12, 26 and 52

  14. All-cause rehospitalizations at 30 and 60 days

    Time frame: From enrollment to 30 and 60 days

  15. Rehospitalizations for worsening heart failure at 30 and 60 days

    Time frame: From enrollment to 30 and 60 days

  16. Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment

    Time frame: From enrollment to the end of follow-up at 52 weeks

  17. Number of urgent and unscheduled outpatient IV diuretic treatment

    Time frame: From enrollment to the end of follow-up at 52 weeks

Other outcomes

  1. Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52

    Time frame: From enrollment to weeks 26 and 52

  2. Type and incidence of SAEs

    Time frame: From enrollment to the end of follow-up at 52 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Pharmacosmos Clinical and non-clinical Department

CONTACT

[email protected]

+45 5948 5959

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Registry information

Official study title

A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Acronym: ICONIC-HF

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 16, 2025
Registry last updated
Jul 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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