Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure (CHF-02)

Pharmacosmos

Status and phase: Not yet enrolling; Phase 3

Conditions: Iron Deficiencies; Chronic Heart Failure

Treatments: Drug: Ferric Derisomaltose

Study type: Interventional

Funder types: Industry

Identifiers

NCT06929806

P-Monofer-CHF-02

Details and patient eligibility

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

Enrollment: 1,900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,900 participants in 2 patient groups

Ferric Derisomaltose

Experimental group

Description:

50 % of the subjects will be treated with Ferric Derisomaltose 100 mg/mL The ferric derisomaltose dose administered is dependent on the subject's weight and hemoglobin (Hb) level. Subjects treated with ferric derisomaltose will be eligible for re-dosing if transferrin saturation (TSAT) remains below \<25 %

Treatment:

Drug: Ferric Derisomaltose

Control

No Intervention group

Description:

50 % of the subjects will receive no IV iron