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 sites650 target enrollmentNovember 7, 2016

ConditionsAcute heart failure with iron deficiency MedDRA version: 20.0Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0Level: LLTClassification code 10000803Term: Acute heart failureSystem Organ Class: 100000011689 MedDRA version: 20.0Level: PTClassification code 10022970Term: Iron deficiencySystem Organ Class: 10027433 - Metabolism and nutrition disorders Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

DrugsFerinject

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Acute heart failure with iron deficiency
Sponsor: Vifor (International) Inc.
Enrollment: 650
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 7, 2016

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Vifor (International) Inc.

Eligibility Criteria

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

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.