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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Derisomaltose | Experimental | 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 % |
|
| Control | No Intervention | 50 % of the subjects will receive no IV iron |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Derisomaltose | Drug | 100 mg/mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of cardiovascular deaths and hospitalizations for worsening heart failure | From enrollment to the end of follow-up at 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pharmacosmos Clinical and non-clinical Department | Contact | +45 5948 5959 | info@pharmacosmos.com |
| Name | Affiliation | Role |
|---|---|---|
| Pharmacosmos Clinical and non-clinical department | Pharmacosmos A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private clinic | Recruiting | Pasadena | California | 91105 | United States |
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| 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 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 |
| 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 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000718030 | ferric derisomaltose |
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