The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on E… (NCT05971732) | Clinical Trial Compass
UnknownPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
China146 participantsStarted 2023-08-01
Plain-language summary
This study will address whether the additional use of Ferric Derisomaltose on top of standard care will improve exercise capacity and quality of life in patients with acute heart failure and iron deficiency. One group of participants will receive treatment with Ferric Derisomaltose and the other group will receive normal saline 0.9% as placebo.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years.
✓. Clinical diagnosis of heart failure with reduced ejection fraction (HFrEF), defined as documented 2-dimensional echocardiography left ventricular ejection fraction (LVEF) \<50% before randomization.
✓. Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation, New York Heart Association (NYHA) class II - IV.
✓. Reaching hemodynamic stability after standard treatment (if tolerated, initiate four pillars of guideline-directed medical therapies). All of the following (i.e., items a to c) must apply:
✓. Systolic blood pressure≥100mmHg, without symptoms of hypotension;
✓. Stop using intravenous diuretics;
✓. Neither intravenous inotropic drugs or vasodilators were used (including nitrates).
✓. Subject is iron deficient defined as serum ferritin \<100 ng/mL or 100 ng/mL ≤ serum ferritin ≤299 ng/mL if TSAT \<20%.
Exclusion criteria
✕. Hematological criteria: ferritin \>400 ug/L; hemoglobin \<9.0, hemoglobin \>13.5 g/dL in women or \>14.5 g/dL in men.
. Heart failure was secondary to valvular diseases or congenital heart diseases.
✕. History of acquired iron overload or hemochromatosis (or first-degree relative of hemochromatosis)
✕. Known hypersensitivity reaction to any component of ferric derisomaltose (Monofer®) or any of its excipients (water for injections, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)).
✕. Non-iron deficiency anaemia.
✕. Already receiving erythropoiesis stimulating agents (ESA) or other iron supplements in previous 4 weeks prior to randomization.