Universitätsklinikum des Saarlandes und Medizinische Fakultät der Universität des Saarlandes

FAIR-HFpEF

Leitung: Prof. Dr. Michael Böhm

Notfall-Informationen

Blutspende am UKS

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♥ Aktuelle Studien

FAIR-HFpEF

Effect of IV iron (ferric carboxymaltose, Ferinject) on exercise tolerance, symptoms and quality of life in patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency with and without anaemia.

INCLUSION Criteria

Patient is willing to participate and provides written informed consent;
Age ≥18 years;
Clinical diagnosis of heart failure with preserved ejection fraction (HFpEF) with LVEF ≥45% at screening or within 6 months prior to planned randomisation
For at least 7 days with NYHA class II or III at time of randomisation (the screening visit can take place at the end of a hospitalisation);
Treated with a diuretic;
Presence of atrial fibrillation (AF) at screening or randomisation is allowed in 2 out of 4 patients
At screening or randomisation, presence of one of the following
criteria:
hospitalisation with a diagnosis of HF within 12 months prior to planned randomisation; OR
raised plasma levels of natriuretic peptides in a patient with sinus rhythm (in patients without AF: NT-proBNP >300 pg/mL or BNP >100 pg/mL or MR-proANP >120 pmol/L; in patients with AF: NT-proBNP >600 pg/mL or BNP >200 pg/mL or MR-proANP >250 pmol/l)
Evidence of diastolic dysfunction at screening or randomisation, defined as:
E/E’ >13; OR LA width ≥38 mm; OR LA length ≥50 mm; OR LA area ≥20 cm2; OR LA volume ≥55 ml; OR left atrial volume index >28 mL/m2;
Haemoglobin >9.0 g/dL and ≤14.0 g/dL (at screening);
ID with ferritin <100 ng/mL or ferritin 100-299 plus TSAT <20% (at screening);
6-minute-walking distance at baseline <450 m (average of the last 2 documented tests within 8 weeks prior to planned randomisation that also need to be within 20% of each other).

EXCLUSION Criteria

Unable to sign informed consent
Any prior echocardiography measurement of LVF <40%;
Clinical signs and symptoms of infection including fever >38°C;
Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;
Use of concurrent immunosuppressive therapy;
History of acquired iron overload or haemochromatosis (or a first relative with haemochromatosis);
Known hypersensitivity to FCM or any other IV iron product;
Known bleeding or haemolytic anemia;
Presence of any condition that precludes exercise testing, such as decompensated HF, significant musculoskeletal disease, unstable angina pectoris, obstructive cardiomyopathy, severe uncorrected valvular disease, or uncontrolled brady-arrhythmias or tachy-arrhythmias;
primary pulmonary hypertension
Severe COPD
body mass index ≥40.0 kg/m2;
Presence of uncontrolled atrial fibrillation with resting heart rate >110/min;
Presence of uncontrolled hypertension with blood pressure >160/100 mm Hg;
Renal replacement therapy;
Concurrent therapy with an erythropoiesis stimulating agent;
Known active malignancy;
Known HIV or active hepatitis infection;
Pregnancy;
Participation in another clinical trial within previous 30 days and/ or anticipated participation in another trial during this study.