NCT06929806 Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
| NCT ID | NCT06929806 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Pharmacosmos A/S |
| Condition | Chronic Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,900 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,900 participants in total. It began in 2025-05-01 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Pharmacosmos Clinical and non-clinical department
STUDY DIRECTOR
Pharmacosmos A/S
Frequently Asked Questions
Who can join the NCT06929806 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06929806 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,900 participants.
Is NCT06929806 currently recruiting?
Yes, NCT06929806 is actively recruiting participants. Contact the research team at info@pharmacosmos.com for enrollment information.
Where is the NCT06929806 trial being conducted?
This trial is being conducted at Pasadena, United States.
Who is sponsoring the NCT06929806 clinical trial?
NCT06929806 is sponsored by Pharmacosmos A/S. The principal investigator is Pharmacosmos Clinical and non-clinical department at Pharmacosmos A/S. The trial plans to enroll 1,900 participants.
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