A multicenter, randomized, double-blind, parallel group, active-controlled study to evaluate the efficacy and safety of both aliskiren monotherapy and aliskiren/enalapril combination therapy compared to enalapril monotherapy, on morbidity and mortality in patients with chronic heart failure (NYHA Class II - IV) - Atmosphere

ovartis0 个研究点目标入组 150 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•See protocol for complete criteria (page34)
•1. Out patients * 18 years of age, male or female.
•2. Patients with a diagnosis of chronic heart failure (NYHA Class II * IV):
•* LVEF * 35% at visit 1 (local measurement, within the past 6 months).
•* Elevated BNP at visit 1: BNP * 150 pg/ml (according to local measurement).
•OR BNP * 100 pg/ml (according to local measurement) and unplanned
•hospitalization with HF within the last 12 months prior visit 1.
•Elevated NT-proBNP at visit 1: BNP * 600 pg/ml (according to local measurement).
•OR NT-proBNP * 400 pg/ml (according to local measurement) and unplanned
•hospitalization with HF within the last 12 months prior visit 1.;3. Patients must be treated with an ACE inhibitor at a stable dose (enalapril 10 mg
•daily at least or any other ACE inhibitor based on equivalent doses described in
•Table 4-1: Dose equivalence guidance table of ACEi's) for at least 4 weeks prior
•to visit 1.
•4. Patients must be treated with a beta blocker, unless contraindicated or not
•tolerated, at a stable dose for at least 4 weeks prior to visit 1 (for patients not
•on target dose, according to local guidelines, or in absence of that medication,
•the reason should be documented).

•See protocol for complete criteria (page34-36)
•2. Patients treated concomitantly with both ARB and aldosterone antagonist in
•addition to study drug at visit 1.
•4. Symptomatic hypotension and/or less than 95 mmHg SBP at Visit 1 and/ or less
•than 90 mmHg SBP at Visits 4.
•5. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or
•major vascular surgery, percutaneous coronary intervention (PCI) or carotid
•angioplasty, within the past 3 months prior to visit 1.
•6. Coronary or carotid artery disease likely to require surgical or percutaneous
•intervention within the 6 months after visit 1.
•18. Serum potassium * 5.0 mmol/L at Visit 1 or * 5.2 mmol/L at Visit 4.
•29. Patients with diabetes mellitus

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