Chronic Heart Failure, High Blood B-type (or Brain) Natriuretic Peptide (BNP) Level
Conditions
Brief summary
This study will compare olmesartan medoxomil to candesartan cilexetil in reducing BNP, a prognostic biomarker of heart failure, at week 24
Interventions
DRUGolmesartan medoxomil + candesartan cilexetil placebo
Dosage form: tablet; frequency: daily; duration: 24 weeks
DRUGolmesartan medoxomil placebo + candesartan cilexetil
Dosage form: tablets; frequency: daily; duration: 24 weeks
Sponsors
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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 If a female becomes pregnant during the study, she has to be withdrawn immediately * Patients with current hospitalisation due to heart failure * Patients with stroke or transient ischemic attack (TIA) within the last 3 months *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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute BNP change from week 0 to 24 of treatment | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| BNP change from week 0 to week 4, 8, and 16 | 16 weeks maximum |
| Incidence of critical events at 24 weeks: All cause death; Cardiovascular death defined as death due to: HF, myocardial infarction, cardiac arrhythmia, stroke/cerebral vascular accident, other cardiovascular cause (e.g., aneurysm or pulmonary embolism) | 24 weeks |
| Event-free survival | 24 weeks |
| Proportion of BNP responders at week 4, 8, 16 and 24 (BNP levels reduced to 350 pg/ml or less at all time points) | 24 weeks maximum |
| Time-to-first cardiovascular event | 24 weeks maximum |
| Change in clinical status: Improvement: patient alive without any cardiovascular event with an improvement of at least one NYHA functional class level; No change: patient alive without any cardiovascular event with stable functional NYHA class | 24 weeks |
| Time-to-death | 24 weeks |
Countries
France, Germany, Netherlands
Outcome results
None listed