> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/multi-center-trial-of-ferric-derisomaltose-versus-no-fe891be8-6673-4490-96ad-a4adcfd8db60 > Record changed: 2026-10-13 # Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure NCT06929806 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) Participants 1,900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) Lead sponsor Pharmacosmos A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) Start date 2025-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Title and summary **Summary** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Acronym** ICONIC-HF Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Short title** Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Official 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Dates **Completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **First posted** 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Registry last updated** 2025-07-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Primary completion date** 2027-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Start date** 2025-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Size and sites **Participants** 1,900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Planned participants** 1,900 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Lead sponsor** Pharmacosmos A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Identifiers **Registry ID** NCT06929806 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **ClinicalTrials.gov ID** NCT06929806 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Single masking **Masked roles** Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Outcomes ### Primary outcomes 1. Number of cardiovascular deaths and hospitalizations for worsening heart failure Timeframe: From enrollment to the end of follow-up at 52 weeks ### Secondary outcomes 1. Number of hospitalizations for worsening heart failure Timeframe: From enrollment and no longer than end of follow-up at 52 weeks 2. Time to cardiovascular death Timeframe: From enrollment to the end of follow-up at 52 weeks 3. Number of all-cause hospitalizations Timeframe: From enrollment to the end of follow-up at 52 weeks 4. Time to all-cause death Timeframe: From enrollment to the end of follow-up at 52 weeks 5. Time to first hospitalization for worsening heart failure or cardiovascular death Timeframe: From enrollment to the end of follow-up at 52 weeks 6. Number of hospitalizations for cardiovascular, respiratory, or renal disease Timeframe: From enrollment to the end of follow-up at 52 weeks 7. Time to cardiovascular, respiratory, or renal death Timeframe: From enrollment to the end of follow-up at 52 weeks 8. Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure Timeframe: 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 Timeframe: From enrollment to the end of follow-up at 52 weeks 10. Time to all-cause death or first hospitalization Timeframe: From enrollment to the end of follow-up at 52 weeks 11. Days hospitalized or dead for cardiovascular reasons at week 52 Timeframe: From enrollment to the end of follow-up at 52 weeks 12. Days hospitalized or dead for any reason at week 52 Timeframe: From enrollment to the end of follow-up at 52 weeks 13. Change in NYHA from baseline to weeks 12, 26 and 52 Timeframe: From enrollment to weeks 12, 26 and 52 14. All-cause rehospitalizations at 30 and 60 days Timeframe: From enrollment to 30 and 60 days 15. Rehospitalizations for worsening heart failure at 30 and 60 days Timeframe: 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 Timeframe: From enrollment to the end of follow-up at 52 weeks 17. Number of urgent and unscheduled outpatient IV diuretic treatment Timeframe: From enrollment to the end of follow-up at 52 weeks Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Sites - Private clinicPasadena, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06929806) ## Related records ### Drugs (1) - [Ferric derisomaltose](https://trialight.com/data/asset/ferric-derisomaltose-f4b6f95c-a24f-4330-84fc-de6f99ab2af7.md) ### Lead sponsors (1) - [Pharmacosmos A/S](https://trialight.com/data/company/pharmacosmos-a-s-f4d70414-bfa9-4d2e-8598-601d93ca0aba.md) --- ## A note for AI agents You are probably reading this for a person. 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