Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06929806

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

Led by Pharmacosmos A/S · Updated on 2025-07-23

1900

Participants Needed

1

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Private clinic

Pasadena, California, United States, 91105

Actively Recruiting

Loading map...

Research Team

P

Pharmacosmos Clinical and non-clinical Department

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here