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

Phase 3RecruitingNCT06929806

Pharmacosmos A/S1,900 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

1,900

Conditions

Chronic Heart Failure Iron Deficiencies

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of cardiovascular deaths and hospitalizations for worsening heart failure

Time frame: From enrollment to the end of follow-up at 52 weeks

Secondary Outcomes

Number of hospitalizations for worsening heart failure

Time frame: From enrollment and no longer than end of follow-up at 52 weeks

Time to cardiovascular death

Time frame: From enrollment to the end of follow-up at 52 weeks

Number of all-cause hospitalizations

Time frame: From enrollment to the end of follow-up at 52 weeks

Time to all-cause death

Time frame: From enrollment to the end of follow-up at 52 weeks

Time to first hospitalization for worsening heart failure or cardiovascular death

Time frame: From enrollment to the end of follow-up at 52 weeks

Number of hospitalizations for cardiovascular, respiratory, or renal disease

Time frame: From enrollment to the end of follow-up at 52 weeks

Time to cardiovascular, respiratory, or renal death

Time frame: From enrollment to the end of follow-up at 52 weeks

Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure

Time frame: From enrollment to the end of follow-up at 52 weeks

Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure

Time frame: From enrollment to the end of follow-up at 52 weeks

Time to all-cause death or first hospitalization

Time frame: From enrollment to the end of follow-up at 52 weeks

Days hospitalized or dead for cardiovascular reasons at week 52

Time frame: From enrollment to the end of follow-up at 52 weeks

Days hospitalized or dead for any reason at week 52

Time frame: From enrollment to the end of follow-up at 52 weeks

Change in NYHA from baseline to weeks 12, 26 and 52

Time frame: From enrollment to weeks 12, 26 and 52

All-cause rehospitalizations at 30 and 60 days

Time frame: From enrollment to 30 and 60 days

Rehospitalizations for worsening heart failure at 30 and 60 days

Time frame: From enrollment to 30 and 60 days

Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment

Time frame: From enrollment to the end of follow-up at 52 weeks

Number of urgent and unscheduled outpatient IV diuretic treatment

Time frame: From enrollment to the end of follow-up at 52 weeks

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts