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Clinical Trials in the USA / NCT06929806
Recruiting Phase 3

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

NCT06929806 · tracked via the Priya Life Science USA tracker
Sponsor
Pharmacosmos A/S
Phase
Phase 3
Started
2025-05-01
Last updated
2026-10-05

Condition(s) studied

Chronic Heart FailureIron Deficiencies

Investigational drug(s) / intervention(s)

Ferric Derisomaltose →

Ferric Derisomaltose: 100 mg/mL

Study 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

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Number of cardiovascular deaths and hospitalizations for worsening heart failure — From enrollment to the end of follow-up at 52 weeks

Trial sites (1)

FacilityCityRegionStatus
Private clinic Pasadena California Recruiting

More Pharmacosmos A/S trials in the USA

Multi-center Trial of Ferric Derisomaltose in Children 0 to <18 Years of Age With Iron Deficiency Anemia Recruiting
Effect of Trilaciclib in the Prevention of Myelosupression in Subjects With Limited-stage Small Cell Lung Cancer Recruiting

Other trials for the same condition

Impact of Two Iron Formulations on Iron Biomarkers and Quality of Life Recruiting
The HEARTFELT Study Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System Recruiting
Voice-based Outcome Identification and Clinical Evaluation in Heart Failure Recruiting
Destination Therapy Post Approval Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06929806 on ClinicalTrials.gov ↗ ← All trials in the USA