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Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)
This is a randomised, double-blind, placebo-controlled Trial (RCT). The 52 weeks observation period following randomisation is considered appropriate to investigate the primary endpoint of recurrent HF hospitalisations and CV death. To evaluate the effect of intravenous ferric carboxymaltose (IV FCM) in iron deficient subjects with AHF, subjects will be enrolled during a hospital stay (Index hospitalisation) after the acute care treatment of the index event has been stabilised. All subjects will continue to receive their established standard therapy for HF and medical emergencies will be treated according to local routine.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
ferric carboxymaltose, Normal saline 0.9%
Clinical Military Hospital
Not yet recruiting
Published on BioPortfolio: 2016-10-19T02:38:21-0400
This study is designed to assess, relative to placebo, the effects on the evolution of exercise capacity and symptomatic status of the addition of iron treatment with FCM (ferric carboxyma...
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who h...
research study of Ferric carboxymaltose to treat fatigue/exhaustion symptoms, believed to be due to iron deficiency.
The primary objective of this study is to examine the efficacy and safety (cardiovascular) of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to IV iron suc...
The goal of this clinical research study is to compare Injectafer® (ferric carboxymaltose) with an iron supplement to learn which may be more effective in improving red blood cell counts ...
Iron deficiency is now recognized as an independent predictor of poor outcome in patients with chronic heart failure and reduced left ventricular ejection fraction. In randomized controlled trials, tr...
In the paediatric population, ferric carboxymaltose (FCM) is only licenced for use in children older than 14 years, and the data in younger children remains scarce. We retrospectively reviewed data o...
Ethylene regulates the plant's response to stress caused by iron (Fe) deficiency. However, specific roles of ERF proteins in response to Fe deficiency remain poorly understood. Here, we investigated t...
The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration.
In preoperative blood management of colorectal cancer patients, intravenous iron therapy is increasingly used to treat anaemia and prevent red blood cell transfusions. However, while iron deficiency i...
The reaction of potassium ferrocyanide with ferric iron to yield a dark blue precipitate at the sites of the ferric iron. Used to determine ferric iron in tissues, particularly in the diagnosis of disorders of iron metabolism.
Iron or iron compounds used in foods or as food. Dietary iron is important in oxygen transport and the synthesis of the iron-porphyrin proteins hemoglobin, myoglobin, cytochromes, and cytochrome oxidase. Insufficient amounts of dietary iron can lead to iron-deficiency anemia.
Iron-containing proteins that are widely distributed in animals, plants, and microorganisms. Their major function is to store IRON in a nontoxic bioavailable form. Each ferritin molecule consists of ferric iron in a hollow protein shell (APOFERRITINS) made of 24 subunits of various sequences depending on the species and tissue types.
A complex of ferric oxyhydroxide with dextrans of 5000 to 7000 daltons in a viscous solution containing 50 mg/ml of iron. It is supplied as a parenteral preparation and is used as a hematinic. (Goodman and Gilman's The Pharmacological Basis of Therapeutics, 8th ed, p1292)
Anemia characterized by a decrease in the ratio of the weight of hemoglobin to the volume of the erythrocyte, i.e., the mean corpuscular hemoglobin concentration is less than normal. The individual cells contain less hemoglobin than they could have under optimal conditions. Hypochromic anemia may be caused by iron deficiency from a low iron intake, diminished iron absorption, or excessive iron loss. It can also be caused by infections or other diseases, therapeutic drugs, lead poisoning, and other conditions. (Stedman, 25th ed; from Miale, Laboratory Medicine: Hematology, 6th ed, p393)