Iron Deficiency

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency

NCT02937454 | PHASE 4 | INTERVENTIONAL

Study to Compare Ferric Carboxymaltose With Placebo in Patients With Acute Heart Failure and Iron Deficiency (Affirm-AHF)

16 Sites

1132 Participants

Recruiting

18 Years to 7 Years

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Find closest sites:

SUBMIT

Hospital Universitario Austral

Buenos Aires,Argentina,1500

InCor Instituto do Corao HCFMUSP

São Paulo,Brazil,05403-900

Clinical Hospital Center Rijeka

Rijeka,Croatia

Aleksandre Aladashvili Clinic LLC

Tbilisi,Georgia,0102

The Baruch Pade Medical Center

Tiberias,Lower Galilee,Israel,15208

Hadassah Ein Kerem University Medical Center

Jerusalem,Israel,91120

Spedali Civilia di Brescia

Brescia,Italy

American University of Beirut Medical Center

Beirut,Lebanon,1107-2020

Vasculair Onderzoek Centrum

Hoorn,Netherlands

Clinical Military Hospital

Wroclaw,Poland,50-891

Emergency Clinical Hospital

Bucharest,Romania,014461

National Heart Centre of Singapore Pte

Singapore,Singapore,169609

University of Murcia

Murcia,Spain,30001

Skane University Hospital

Malmö,Sweden,SE20502

The M.D. Strazhesko Institute of Cardiology

Kyiv,Ukraine,02000

Kings College Hospital NHS Foundation

London,United Kingdom

Study 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:
1. Upon admission for the AHF episode, persistent dyspnoea at rest in a recumbent sitting position (30-45°) or with minimal exertion
2. Upon or during the AHF admission, at least 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)
3. Natriuretic peptide levels, measured ≤72 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
4. AHF episode treated with minimally 40 mg of IV furosemide (or equivalent IV loop diuretic defined as 20 mg of torasemide 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.

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. (Note that it does NOT include short-term prophylactic administration of antibiotics or short-term temperature elevation at admission which is no longer present at the time point of discharge/randomisation).
3. Documented restricted amyloid myocardiopathy, or acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy. (Note that it does NOT include restrictive mitral filling patterns seen on Doppler echocardiographic assessments of diastolic function).
4. Clinical evidence of acute coronary syndrome, transient ischemic attack or stroke, within the last 30 days prior randomisation.
5. Severe valvular or left ventricular outflow obstruction disease needing intervention.
6. 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.
7. Subject has a body weight \<35 kg at randomisation.
8. Subject at an immediate need of transfusion or with a Hb \<8 g/dL\* or with a Hb \>15 g/dL.
9. Subjects on treatment for Vitamin B12 and/or serum folate deficiency. Note: Use of Vitamin B12 and folic acid as supplement therapy (not for deficiency treatment) is permitted.
10. 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.
11. Subject has known hypersensitivity to any of the study products to be administered or k

Additional Studies

Additional studies can be found at ClinicalTrials.gov