Study to Demonstrate the Non-inferiority of Olmesartan Medoxomil Versus Candesartan Cilexetil in Reducing Blood B-type (or Brain) Natriuretic Peptide Levels at Week 24

A 24-Week Multicentre, Randomized, Double-Blind, Controlled, Parallel Group Non-Inferiority Study to Assess the Efficacy and Safety of Olmesartan Medoxomil Versus Candesartan Cilexetil in Patients With Symptomatic Heart Failure (NYHA II-IV)

This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24

Inclusion Criteria:

• Male or female, adult, out-patients aged between 18 and 85 years
• Patients with documented hospital admission within the previous 3 months before randomization with discharge diagnosis of CHF
• Patients with functional NYHA class II-IV with LVEF < 40% assessed within the last 3 months
• Patients with blood BNP levels > 400 pg/ml or NT-ProBNP levels > 1500 pg/ml
• Patients with CHF due to ischemic heart disease, idiopathic dilated cardiomyopathy (IDC), mitral or aortic insufficiency or hypertension
• Patients with stable conventional treatment with diuretics, ACEI and/or beta-blockers and/or aldosterone antagonists for at least 2 months prior to randomisation, unless documented contraindication or intolerance

Exclusion Criteria:

• Females who are pregnant or plan a pregnancy during the time of the trial, are nursing or are of childbearing potential and not using acceptable methods of contraception. If a female becomes pregnant during the study, she has to be withdrawn immediately
• Patients with current hospitalisation due to heart failure
• Patients with stroke or transient ischemic attack (TIA) within the last 3 months
• Patients with acute coronary syndrome, myocardial infarction, coronary artery bypass or angioplasty within 3 months
• Planned cardiac surgery, revascularization or resynchronization within the study period
• Patients with operable valvular disease or significant obstructive cardiomyopathy
• Patients with bradycardia [heart rate (HR) < 50 bpm]
• Patients with hypotension [systolic blood pressure (SBP) < 90 mmHg]
• Patients with obstructive pneumopathy
• Patients with clinical significant renal failure (creatininemia > 200 micromol/l)