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

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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Heart Failure; Iron Deficiencies
• Intervention / Treatment: Drug: Ferric Derisomaltose

• Study Type: Interventional
• Enrollment (Estimated): 1900
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pharmacosmos Clinical and non-clinical Department; Phone Number: +45 5948 5959; Email: info@pharmacosmos.com

Study Locations

• United States
  • California
    • Pasadena, California, United States, 91105
      • Recruiting
      • Private Clinic
      • Contact: MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ferric Derisomaltose; 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 %	Drug: Ferric Derisomaltose; 100 mg/mL
No Intervention: Control; 50 % of the subjects will receive no IV iron

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of cardiovascular deaths and hospitalizations for worsening heart failure	From enrollment to the end of follow-up at 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of hospitalizations for worsening heart failure	From enrollment and no longer than end of follow-up at 52 weeks
Time to cardiovascular death	From enrollment to the end of follow-up at 52 weeks
Number of all-cause hospitalizations	From enrollment to the end of follow-up at 52 weeks
Time to all-cause death	From enrollment to the end of follow-up at 52 weeks
Time to first hospitalization for worsening heart failure or cardiovascular death	From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular, respiratory, or renal disease	From enrollment to the end of follow-up at 52 weeks
Time to cardiovascular, respiratory, or renal death	From enrollment to the end of follow-up at 52 weeks
Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure	From enrollment to the end of follow-up at 52 weeks
Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure	From enrollment to the end of follow-up at 52 weeks
Time to all-cause death or first hospitalization	From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for cardiovascular reasons at week 52	From enrollment to the end of follow-up at 52 weeks
Days hospitalized or dead for any reason at week 52	From enrollment to the end of follow-up at 52 weeks
Change in NYHA from baseline to weeks 12, 26 and 52	From enrollment to weeks 12, 26 and 52
All-cause rehospitalizations at 30 and 60 days	From enrollment to 30 and 60 days
Rehospitalizations for worsening heart failure at 30 and 60 days	From enrollment to 30 and 60 days
Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment	From enrollment to the end of follow-up at 52 weeks
Number of urgent and unscheduled outpatient IV diuretic treatment	From enrollment to the end of follow-up at 52 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52	From enrollment to weeks 26 and 52
Type and incidence of SAEs	From enrollment to the end of follow-up at 52 weeks

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S
• Investigators: Study Director: Pharmacosmos Clinical and non-clinical Department, Pharmacosmos A/S

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: April 8, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 16, 2025

Study Record Updates

• Last Update Posted (Actual): July 23, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Metabolic Diseases; Iron Metabolism Disorders; Iron Deficiencies; Heart Failure
• Other Study ID Numbers: P-Monofer-CHF-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No