Clinical trial NCT06929806: Multi-center Trial of Ferric Derisomaltose Versus no Intravenous Iron in Iron-deficient Subjects With Symptomatic Chronic Heart Failure
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Chronic Heart Failure
Iron Deficiencies
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
First posted: 2025-04-16
Enrollment: 1900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


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

Primary outcomes:
measure: Number of cardiovascular deaths and hospitalizations for worsening heart failure
timeFrame: From enrollment to the end of follow-up at 52 weeks
Secondary outcomes:
measure: Number of hospitalizations for worsening heart failure
timeFrame: From enrollment and no longer than end of follow-up at 52 weeks
measure: Time to cardiovascular death
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Number of all-cause hospitalizations
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Time to all-cause death
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Time to first hospitalization for worsening heart failure or cardiovascular death
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Number of hospitalizations for cardiovascular, respiratory, or renal disease
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Time to cardiovascular, respiratory, or renal death
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Time to cardiovascular death or first hospitalization for cardiovascular event: stroke, AMI and heart failure
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Time to all-cause death or first hospitalization
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Days hospitalized or dead for cardiovascular reasons at week 52
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Days hospitalized or dead for any reason at week 52
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Change in NYHA from baseline to weeks 12, 26 and 52
timeFrame: From enrollment to weeks 12, 26 and 52
measure: All-cause rehospitalizations at 30 and 60 days
timeFrame: From enrollment to 30 and 60 days
measure: Rehospitalizations for worsening heart failure at 30 and 60 days
timeFrame: From enrollment to 30 and 60 days
measure: Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment
timeFrame: From enrollment to the end of follow-up at 52 weeks
measure: Number of urgent and unscheduled outpatient IV diuretic treatment
timeFrame: From enrollment to the end of follow-up at 52 weeks
Other outcomes:
measure: Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52
timeFrame: From enrollment to weeks 26 and 52
measure: Type and incidence of SAEs
timeFrame: From enrollment to the end of follow-up at 52 weeks
Locations:
Study officials:
affiliation: Pharmacosmos A/S
name: Pharmacosmos Clinical and non-clinical department
role: STUDY_DIRECTOR
References: