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RecruitingPhase 3

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

Pharmacosmos A/S · NCT06929806

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1900
US sites recruiting
1
Study start
May 1, 2025
Record last updated
October 5, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: Ferric Derisomaltose

Conditions: Chronic Heart Failure; Iron Deficiencies

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

Recruiting US locations

Study contacts (from the official record)

  • Pharmacosmos Clinical and non-clinical Department · +45 5948 5959 · info@pharmacosmos.com
All heart & blood pressure studies in California →
Multi-center Trial of Ferric Derisomaltose Versus no Intravenous… (NCT06929806) | Bored Studies