Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction (NCT03074591) | Clinical Trial Compass
CompletedPhase 4
Effect of IV Iron in Patients With Heart Failure With Preserved Ejection Fraction
Germany40 participantsStarted 2017-08-01
Plain-language summary
This study addresses, whether treatment with IV iron for patients with heart failure with preserved ejection fraction (HFpEF) and iron deficiency (ID), both with or without anaemia, can improve exercise capacity as measured by 6-minute walking test (6-MWT) and symptoms while being safe
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (assessed by echocardiography or MRI);
✓. Ambulatory 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 (calculated per centre);
✓. 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
Exclusion criteria
✕. Unable to sign informed consent
✕. Any prior echocardiography measurement of LVEF \<40%;
✕. Clinical signs and symptoms of infection including fever \>38°C;
✕. Use of IV iron, erythropoietin or blood transfusions within the previous 60 days;