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
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
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
Parallel
Ferric Derisomaltose
Drug100 mg/mL
Number of cardiovascular deaths and hospitalizations for worsening heart failure
Number of hospitalizations for worsening heart failure
Time to cardiovascular death
Number of all-cause hospitalizations
Time to all-cause death
Change in hb, s-ferritin, TSAT, s-iron and TIBC from baseline to weeks 26 and 52
Type and incidence of SAEs
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