EUCTR2009-010208-27-DE进行中（未招募）不适用
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.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients must give written informed consent to participate in the study and before any study related assessments are performed.
- •2. Male or female outpatients, = 40 years of age.
- •3. Patients with documented stable chronic heart failure (NYHA II-IV):
- •LVEF = 45% (local measurement, assessed by echocardiography, MUGA, CT scan, MRI or ventricular angiography); the ejection fraction must have been obtained within 6 months prior to randomization or after any MI or other event that would affect ejection fraction.
- •Plasma NT-proBNP > 400 pg/ml at Visit 1.
- •Patients with documented stable chronic heart failure (NYHA II-IV).
- •Patients receiving ACE inhibitors (ACEi), an angiotensin receptor blockers (ARB) and/or a beta blockers must be on a stable dose of these medications for the 1 month period prior to Visit 1.
- •Patients must be on diuretic therapy prior to Visit 1 (flexible dosing is permitted).
- •Patients with a controlled systolic BP, defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP at randomization (Visit 2).
- •4. Patients with at least one of the following symptoms at the time of screening (Visit 1):
- •– Dyspnea on exertion
- •– Orthopnea
- •– Paroxysmal nocturnal dyspnea
- •– Peripheral edema
- •5. Patients must have an eGFR = 30 ml/min/1.73 m2 at Visit 1 (calculated by the Modification of Diet in Renal Disease formula).
- •6. Patients with a potassium =5.2 mmol/l at Visit 1.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patients with a prior LVEF reading <45%, at any time.
- •2. Patients who require treatment with both an ACE inhibitor and an ARB.
- •3. Isolated right heart failure due to pulmonary disease.
- •4. Dyspnea and/or edema from non-cardiac causes, such as lung disease, anemia, or severe obesity.
- •5. Presence of hemodynamically significant mitral and/or aortic valve disease.
- •6. Presence of hemodynamically significant obstructive lesions of left ventricular outflow tract, including aortic stenosis.
- •7. Presence of hypertrophic obstructive cardiomyopathy.
- •8. Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloid disease).
- •9. Patients with a history of any organ transplant or who were on a transplant list (life expectancy < 6 months at time of entry into the study).
- •10. Patients with a mean sitting systolic blood pressure =100 mm Hg.
- •11. Coronary artery disease likely to require coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) during the course of the study. Patients with angina pectoris requiring pharmacological therapy are allowed entry into the study.
- •12. History of myocardial infarction, unstable angina, coronary bypass surgery or any PCI, stroke or TIA during the past 3 months prior to Visit 1.
- •13. Clinically significant second or third degree heart block without a pacemaker.
- •14. Atrial fibrillation with a resting heart rate >100 beats per minute (bpm).
- •15. Patients with an implantable cardioverter defibrillator (ICD) that has discharged in the past 1 month of Visit 1.
- •For detailed exclusion criteria see the full protocol.
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