Safety & Efficacy of ALT-711 (Alagebrium) in Chronic Heart Failure

Inclusion Criteria:

NYHA II-IV heart failure
Echocardiographic ejection fraction ≤ 45% (echo does not need to be repeated at the screening visit if a prior echo is on record which indicates an ejection fraction < 40%)
Duration of heart failure > 3 months
Stable heart failure medical therapy for > 1 month
Patients need to be able to understand content of and willing to provide informed consent

Exclusion Criteria:

Patient ≤ 18 years
History of myocardial infarction in previous 6 months
History of stroke/TIA/RIND in previous 6 months
Severe valvular dysfunction
Severe pulmonary disease
History of systemic inflammatory or collagen vascular disease
Active and or treated malignancies within 12 months prior to inclusion
Any significant condition either medical or non-medical that could lead to difficulty complying with the protocol
Patients on cardiac resynchronisation therapy (CRT) or scheduled for CRT implantation
Pacemaker therapy (unless rescue pacing at ≤ 40 bpm) or scheduled pacemaker implantation
History of valve replacement or surgery
Uncontrolled diabetes mellitus (HbA1c > 9.5%)
Clinically significant renal disturbance (sMDRD calculated GFR≤30 mL/min/1.73m2; sMDRD is calculated as 186 x serum Cr (mg/dl)-1.154 x years-0.203 x (0.742 if female) x (1.210 if African American)
Clinically significant liver disease (ASAT/ALAT > 2,5 times the upper limit of normal)
Severe anemia at baseline (Hemoglobin <10 g/dl or <6.2 mmol/l)
Use of any investigational drug(s) within 30 days prior to screening
Pregnancy or active breast-feeding (urine pregnancy tests will be performed on all female subjects of childbearing potential)*
Active pericarditis/myocarditis
The inability of patients to undergo exercise testing