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)
- Conditions
- Iron DeficiencyAcute heart failure with iron deficiencySudden insufficiency of cardiac function associated with low iron content of the blood10019280
- Registration Number
- NL-OMON49709
- Lead Sponsor
- Vifor (International) Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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 ;ii. BNP *600 pg/mL or NT-proBNP *2,400 pg/mL for subjects presenting with atrial fibrillation when the blood sample was taken;d AHF episode treated with minimally 40 mg of IV furosemide (or equivalent IV loop diuretic defined as 20 mg of torsemide or 1 mg of bumetanide);2. Subject is iron deficient defined as serum ferritin <100 ng/mL or 100 ng/mL * serum ferritin *299 ng/mL if TSAT <20%.;3. Left ventricular ejection fraction <50% (assessed and documented within 12 months prior to randomisation).;4. Male or female aged *18 years old.;5. Subject (or legally acceptable representative)* has provided the
appropriate written informed consent. Subject must provide written
informed consent before any study-specific procedures are performed.
*Following section in Italics are applicable for the Netherlands only (NL
only): The option that legally accepted representatives of subjects can
sign the written informed consent is not valid for sites in the
Netherlands
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.;8. Subject has known hypersensitivity to any of the study products to be administered or known serious hypersensitivity to other parenteral iron products.;9. Renal dialysis (previous, current or planned within the next 6 months).;10. Chronic liver disease (including active hepatitis) and/or alanine transaminase or aspartate transaminase above 3 times the upper limit of the normal range.;11. Subjects with known hepatitis B surface antigen positivity and/or hepatitis C virus ribonucleic acid positivity.;12. Subject is pregnant (e.g., positive human chorionic gonadotropin
test) or breast feeding.;*Following section in Italics are applicable for the Netherlands only (NL only): The lower threshold of Hb values is set to 10 g/dL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Endpoint<br /><br>* The composite of recurrent HF hospitalisations and CV death up to 52 weeks<br /><br>after randomisation</p><br>
- Secondary Outcome Measures
Name Time Method