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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

A Phase III, Randomized, Open-label, Blinded Endpoint, Comparative Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether ferric derisomaltose, an iron treatment given through a vein, helps adults with low iron and long-term heart failure that causes symptoms. Researchers will compare it with no IV iron to see how many people go to the hospital or die from heart or blood vessel disease. Both groups will get standard care.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 or older. Both men and women can join.
  • Have heart failure that causes tiredness, shortness of breath, or other symptoms during physical activity.
  • Have a heart pumping measure called ejection fraction of 45% or less in the heart’s main pumping chamber.
  • Have low iron levels in the blood.
  • Have heart failure rated class II, III, or IV on the NYHA scale, which rates how much symptoms limit activity.

Who can't join

  • Have plans for heart surgery, a procedure to improve blood flow to the heart, or placement of a heart device.
  • Be pregnant or breastfeeding.
  • Have received iron through a vein or by a shot into a muscle in the past 6 months.
  • Be receiving radiation treatment or chemotherapy.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA