Ferric Derisomaltose for Chronic Heart Failure with Iron Deficiency

This study is looking at whether an intravenous (IV) iron treatment called ferric derisomaltose can help people with chronic heart failure (a condition where the heart can't pump enough blood) who also have low iron levels. The main goal is to see if ferric derisomaltose can reduce the number of times people are hospitalized for worsening heart failure or die from heart-related problems. You may be able to join if you are 18 or older, have symptomatic heart failure with reduced pumping ability (ejection fraction 45% or less), and have low iron. Researchers will compare those who receive ferric derisomaltose to those who don't. The study aims to enroll 1900 participants, but its current recruitment status is unclear.

Study design
This is an interventional study where participants will be randomly assigned (like flipping a coin) to either receive ferric derisomaltose or no ferric derisomaltose, with 1900 participants planned.
What's involved
You will visit the study site 4-5 times and have 7 video or phone calls. All participants will receive standard medical care for their condition.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from enrollment until 52 weeks (about one year) after the study begins.

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NCT06929806

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Pharmacosmos A/S
~1,900 participants
Updated 2025-07-23 on ClinicalTrials.gov
What's tested:Ferric Derisomaltose

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of cardiovascular deaths and hospitalizations for worsening heart failure
Measured over From enrollment to the end of follow-up at 52 weeks
Chronic Heart Failure
Iron Deficiencies
1 sites across 1 states
California1
  • Pharmacosmos Clinical and non-clinical department · STUDY_DIRECTOR · Pharmacosmos A/S
Pharmacosmos Clinical and non-clinical Department
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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