NL-OMON35586已完成2 期
A 36-week, randomized, double-blind, multi-center, parallel group, active controlled study to evaluate the efficacy, safety and tolerability of LCZ696 compared to valsartan in patients with chronic heart failure and preserved left-ventricular ejection fraction. - LCZ696B2214
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- ovartis
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •See protocol for complete criteria (page 21 -22)
- •2) Male or female outpatients, * 40 years of age
- •3) Patients with documented stable chronic heart failure (NYHA II - IV) and:
- •- LVEF * 45% (local measurement, within the past 6 months or after any event that would effect ejection fraction)
- •- Plasma NT-proBNP > 400 pg/ml at Visit 1
- •- Patients must be on diuretic therapy prior to Visit 1 (flexible dose permitted)
- •4) Patients with at least one of the following symptoms at visit 1:
- •- Dyspnea on exertion
- •- Orthopnea
- •- Paroxysmal nocturnal dyspnea
- •- Peripheral edema
排除标准
- •See protocol for complete criteria pages 22-24
- •1) Patients with a prior LVEF reading <45%, at any time
- •2) Patient who require treatment with both an ACE inhibitor and an ARB
- •3) Isolated right heart failure due to pulmonary disease
- •4) Dyspnea and/ore edema from non-cardiac causes, such as lung disease, anemia, or severe obesity
- •7) Presence of hypertrophic obstructive cardiomyopathy
- •8) Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infiltrative cardiomyopathy
- •12) History of MI, unstable angina, coronary bypass surgery or any PCI, stroke or TIA during the past 3 months prior to visit 1
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