EFfect of Ferric Carboxymaltose on exercIseCApacity and Cardiac function in patients with irondeficiencY and chronic Heart Failure(EFFICACY-HF) - EFFICACY-HF

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 330

Inclusion Criteria

At least 18 years of age who have provided written informed consent; In NYHA (New York Heart Association) functional class II or III, Ambulatory and capable of performing a 6-minute walk test; Treated for CHF (congestive heart failure) during at least one hospital, emergency room or acute clinic admission within the last 24 months or brain natriuretic peptide (BNP) = 100 pg/ml or N-terminal pro-hormone brain natriuretic peptide (NT-proBNP) = 400 pg/ml, not older than 8 weeks when study treatment is started; Currently treated for CHF for at least 4 weeks with the same combination of at least two of the following: (a) diuretic, (b) beta-blocker (including carvedilol), (c) ACE (angiotensin converting enzyme inhibitor) or ARB (angiotensin II receptor blocker); Treated during the last 2 weeks with the same dose of drugs given for CHF (dose changes of diuretics are allowed); Resting cuff blood pressures = to 160 mm Hg systolic and = 100 mm Hg diastolic (at the disappearance of sounds, Korotkoff phase V); LVEF (left-ventricular ejection fraction) = 40% assessed locally by 2D Echocardiography; Screening Hb (haemoglobin) value = 9.5 g/dL (5.9 mmol/L), and = 13.5 g/dL (8.4 mmol/L). Screening ferritin below 100 µg/L (224.7 pmol/l), or below 300 µg/L (674.1 pmol/l) when TSAT (transferrin saturation) is below 20%; Use of adequate contraceptive methods for women of childbearing potential.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Unstable angina pectoris; Walking distance limited by intermittent claudication; Significant valvular disease or left ventricular outflow obstruction; Poorly controlled rapid atrial fibrillation or flutter, symptomatic brady- or tachyarrhythmia; Chronic liver disease; Active infection, clinically significant bleeding, life expectancy reduced by malignancy or known HIV/AIDS (human immunodeficiency virus/acquired immune deficiency syndrome); Anaemia due to reasons other than iron deficiency (e.g. haemoglobinopathy); On immunosuppressive therapy or renal dialysis; Pregnant or lactating; Hospitalisation, emergency room or acute clinic admission for CHF within the last 2 weeks; AMI (acute myocardial infarction) or CVA (cerebrovascular accident) within the last 12 weeks; PCI (percutaneous coronary intervention), CABG (coronary artery bypass graft), major surgery, CRT, ICD or ICD-CRT implantation within the last 12 weeks (diagnostic angiography is allowed); History of acquired iron overload or hypersensitivity to FCM (ferric carboxymaltose) or to any of its excipients; Erythropoiesis Stimulating agents (ESAs), i.v. or blood transfusion administered within the last 12 weeks, or oral iron therapy within the last 30 days; Participation in another clinical trial within the last 30 days; Inadequate quality for central analysis of locally recorded 2D Echo/Doppler cardiograms; Screening ALT (alanine transaminase) or AST (aspartate aminotransferase) > three times the local upper limit of normal; CRP (C-reactive protein) >20 mg/L; Immunosuppressive therapy, renal dialysis, EPO, i.v. or oral iron therapy, or blood transfusion planned; Present abuse of alcohol or drugs; Anticipated participation in another trial during this trial; Inability to fully comprehend and/or comply with trial procedures in the investigator’s opinion.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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