A randomised, controlled, observer-blinded phase III clinical trial to compare the effect of intravenous ferric carboxymaltose to placebo on exercise capacity and cardiac function in patients with chronic heart failure and iron deficiency - EFfect of Ferric Carboxymaltose on exercIse CApacity and Cardiac function in patients with iron deficiencY and chronic Heart Failure

Phase 3

Conditions: Heart failure
iron deficiency
10019280

Registration Number: NL-OMON32525

Lead Sponsor: Vifor Pharma - Vifor International AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 60

Inclusion Criteria

Heart failure patients with EF 40% or lower, NYHA class II or III; Patients have been treated (unplanned hospitalisation or acute care admission) for congestive heart failure within last 24 months; Patients are treated for at least 4 weeks with standard heart failure medication, and 2 weeks without change in medication; Hemoglobin between 5,9 mmol/L and 8,4 mmol/L.
Ferritin < 100 microgram/L, or ferritin < 300 microgram/L and transferrin saturation < 20%.

Exclusion Criteria

Anemia by other causes than iron deficiency, Unstable angina pectoris.
Walking distance limited by intermittent claudication.
Significant valvular disease or outflow tract obstruction.
Immunosuppressive therapy or renal dialysis.
Recent (within 12 weeks) myocardial infarction, percutaneous coronary intervention or CABG.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. Evolution from baseline of the distance covered in the six-minute walk tests<br /><br>performed at 4, 12 and 24 weeks after the start of study treatment.<br /><br>2. Evolution from baseline in New York Heart Association (NYHA) functional<br /><br>class assessed at weeks 4, 12 and 24 weeks after the start of study treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Evolution from baseline of cardiac function parameters as assessed by 2D<br /><br>Echo/Doppler cardiography at 4, 12 and 24 weeks.<br /><br>2. Self-reported patient global assessment of treatment at 4, 12 and 24 weeks.<br /><br>3. Quality of life as assessed by the European Quality of Life * 5 Dimensions<br /><br>and Kansas City Cardiomyopathy Questionnaire questionnaires at 4, 12 and 24<br /><br>weeks</p><br>