Ferric derisomaltose versus no IV iron for people with symptomatic chronic heart failure and iron deficiency
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
Run by Pharmacosmos A/S · NCT06929806 · Data updated 2026-11-12
This trial will test whether giving IV ferric derisomaltose to people with symptomatic chronic heart failure and low iron lowers the chance of hospitalization or death from heart or blood vessel disease.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1900 (estimated) |
| Sponsor | Pharmacosmos A/S Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pasadena, California) |
| Status | Recruiting |
| Started | May 1, 2025 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT06929806 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 and older with symptomatic chronic heart failure (NYHA II–IV), left ventricular ejection fraction ≤45%, and laboratory evidence of iron deficiency who have not received IV or IM iron in the past 6 months are the intended participants.
✕Probably not a fit
People without iron deficiency, those with LVEF >45%, pregnant or nursing women, those planning imminent cardiac procedures, or those recently treated with IV/IM iron are unlikely to benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3, randomized study assigns participants 50/50 to receive either IV ferric derisomaltose or no IV iron while all continue standard heart failure care. The main outcome is the number of participants hospitalized or dying from cardiovascular causes. Participants will attend 4–5 in-person visits and have up to 7 phone/video contacts for follow-up. The sponsor listed is Pharmacosmos A/S and the listed site is a private clinic in Pasadena, California.
Why it matters
Potential benefit: If successful, the treatment could reduce cardiovascular hospitalizations and deaths and improve outcomes for people with heart failure and iron deficiency.
How similar studies have gone: Other IV iron formulations have shown symptom and hospitalization benefits in heart failure with iron deficiency, so the approach has supporting evidence though ferric derisomaltose itself has fewer large outcome trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Private clinic
Pasadena, California, United States Recruiting
Study contacts
- Study coordinator: Pharmacosmos Clinical and non-clinical Department
- Email: info@pharmacosmos.com
- Phone: +45 5948 5959
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.