EUCTR2016-001467-36-PLActive, not recruitingPhase 1
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Vifor (International) Inc.
- Enrollment
- 650
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •iii. For subjects treated with an angiotensin receptor neprilysin inhibitor (ARNI) in the previous 4 weeks prior to randomisation only NT-proBNP values should be considered
- •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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 600
Exclusion Criteria
- •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.
Investigators
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