Lack of subject recruitment

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 If a female becomes pregnant during the study, she has to be withdrawn immediately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)

De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.

Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.