Chronic Heart Failure, Iron Deficiencies
Conditions
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
Interventions
100 mg/mL
Sponsors
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of cardiovascular deaths and hospitalizations for worsening heart failure | From enrollment to the end of follow-up at 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Time to all-cause death or first hospitalization | From enrollment to the end of follow-up at 52 weeks |
| Days hospitalized or dead for cardiovascular reasons at week 52 | From enrollment to the end of follow-up at 52 weeks |
| Number of hospitalizations for worsening heart failure | From enrollment and no longer than end of follow-up at 52 weeks |
| Time to cardiovascular death | From enrollment to the end of follow-up at 52 weeks |
| Number of all-cause hospitalizations | From enrollment to the end of follow-up at 52 weeks |
| Time to all-cause death | From enrollment to the end of follow-up at 52 weeks |
| Time to first hospitalization for worsening heart failure or cardiovascular death | From enrollment to the end of follow-up at 52 weeks |
| Number of hospitalizations for cardiovascular, respiratory, or renal disease | From enrollment to the end of follow-up at 52 weeks |
| Time to cardiovascular, respiratory, or renal death | From enrollment to the end of follow-up at 52 weeks |
| Number of cardiovascular deaths and hospitalizations for worsening heart failure including urgent and unscheduled outpatient IV diuretic treatment | From enrollment to the end of follow-up at 52 weeks |
| Number of urgent and unscheduled outpatient IV diuretic treatment | From enrollment to the end of follow-up at 52 weeks |
| Number of hospitalizations for cardiovascular events: stroke, AMI and heart failure | 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 | From enrollment to the end of follow-up at 52 weeks |
| Days hospitalized or dead for any reason at week 52 | From enrollment to the end of follow-up at 52 weeks |
| Change in NYHA from baseline to weeks 12, 26 and 52 | From enrollment to weeks 12, 26 and 52 |
| All-cause rehospitalizations at 30 and 60 days | From enrollment to 30 and 60 days |
| Rehospitalizations for worsening heart failure at 30 and 60 days | From enrollment to 30 and 60 days |
Other
| Measure | Time frame |
|---|---|
| Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52 | From enrollment to weeks 26 and 52 |
| Type and incidence of SAEs | From enrollment to the end of follow-up at 52 weeks |
Countries
United States
Contacts
Primary ContactPharmacosmos Clinical and non-clinical Department
Outcome results
None listed