A Randomised, Double-blind Placebo Controlled Trial Comparing the Effect of Intravenous Ferric Carboxymaltose on Hospitalisations and Mortality in Iron Deficient Patients Admitted for Acute Heart Failure (Affirm-AHF) - Affirm-AHF

VIFOR (INTERNATIONAL) INC.0 sites1,110 target enrollmentAugust 3, 2021

Overview

No summary available.

Registry

who.int

Start Date

August 3, 2021

End Date

July 21, 2020

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1 Currently hospitalised for an episode of acute heart failure (AHF) where AHF was the primary reason for hospitalisation. All of the following (i.e., items a to d) must apply:
•a. Upon admission for the AHF episode, persistent dyspnoea at rest in a recumbent sitting position (30\-45°) or with minimal exertion
•b. Upon or during the AHF admission, at least two (2\) of the following clinical findings were present:
•i. Congestion on chest x\-ray
•ii. Rales on chest auscultation
•iii. Oedema \=1\+ on a 0\-3\+ scale, indicating indentation of skin with mild digital pressure that requires 10 or more seconds to resolve in any
•dependent area including extremities or sacral region
•iv. Elevated jugular venous pressure (\=8 cm H2O)
•c Natriuretic peptide levels, measured \=24 hours of the AHF admission must have been:
•i. Brain natriuretic peptide (BNP) \=400 pg/mL or N\-terminal\-pro\-brain natriuretic peptide (NT\-proBNP) \=1,600 pg/mL or

•1\. Dyspnoea due to non\-cardiac causes such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, acute bronchitis, pneumonia, primary pulmonary
•hypertension).
•2\. Temperature \>38°C (oral or equivalent), active infective endocarditis, sepsis, systemic inflammatory response syndrome, or any other active
•infection requiring anti\-microbial treatment at any time during an Index hospitalisation.
•3\. Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days prior randomisation.
•4\. Coronary\-artery bypass graft, cardiac resynchronisation therapy device implantation, percutaneous intervention (e.g., cardiac,
•cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery that led to significant blood loss, including thoracic and cardiac surgery, within the last 3 months prior to randomisation.
•5\. Subject has a body weight \<35 kg at randomisation.
•6\. Subject at an immediate need of transfusion or with a Hb \<8 g/dL\* or with a Hb \>15 g/dL.
•7\. Subject with a known anaemia not attributed to ID (e.g., other microcytic anaemia) or with an evidence of iron overload (e.g., haemochromatosis) or disturbances in the utilisation of iron.