PER-026-99已完成未知
Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events (OVERTURE)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
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
入选标准
- •1.Age>18years
- •2.Men or women. Women may not be pregnant or nursing. Women of child bearing potential (WOCBP) are eligible if they are practicing effective contraceptive measures.
- •3.Chronic heart failure of NYHA Functional Class II, III or IV in severity for at least 2 months. Subjects with no symptoms attributable to heart failure (Class I) are not eligible.
- •4.Hospitalization for worsening heart failure within the past 12 months.
- •5.The following medications are required, recommended or allowed at the time of enrolment into the study: Diuretics, ACE Inhibitors, Beta-blockers, Angiotensin II receptor blockers, Other Cardiac Therapies.
- •6.Willing and able to give informed consent.
- •7.Evidence by invasive or noninvasive cardiac imaging of left ventricular systolic dysfunction.
排除标准
- •1.Previous intolerance to ACE inhibitors, as indicated by a history of discontinuation of ACE-I due to urticaria, cough, bronchospasm, or angioedema.
- •2.Hemodynamically significant primary cardiac valvular disease, hypertrophic or restrictive cardiomyopathy, constrictive pericarditis, cor pulmonale or a history of myocarditis (including Chagas disease).
- •3.A heart transplant or left ventricular assist device or partial left ventricular resection (Batista procedure).
- •4.Unstable angina pectoris or myocardial infarction within 1 month or a coronary revascularization procedure (coronary artery bypass grafting or percutaneous transluminal angioplasty) within 3 months prior to enrolment.
- •5.Transient ischemia attack (TIA) or stroke within 3 months prior to enrolment.
- •6.Any of the following rhythm abnormalities:
- •a.Second or third degree heart block or sick sinus syndrome (unless treated with a properly functioning pacemaker).
- •b.History of resuscitated ventricular tachycardia, ventricular fibrillation or sudden death, unless (1) these occurred within 24 hours of an acute myocardial infarction; or (2) the subject has an implanted and properly functioning implantable cardioverter-defibrillator (ICD) which has not fired within 2 months prior to enrolment.
- •7.Any of the following medications within 2 weeks prior to enrollment: - Oral positive inotropic drugs (except digitalis) or - Lithium salts
- •8.Any of the following therapies:
- •a.Intravenous therapy with a positive inotropic agent in an outpatient or short-stay unit within 2 weeks prior to enrollment.
- •b.Therapy with omapatrilat (when approved for any indication) within 30 days of enrollment or prior history of intolerance to omapatrilat
- •c.Treatment with an investigational drug within 30 days
- •d.Participation in any other clinical trial of drug therapy until the present study has been terminated or completed.
- •9.Participation in an earlier trial with omapatrilat (regardless of treatment received)
- •10.Concomitant disorders that might compromise the ability to evaluate treatment or enhance the risks of therapy.
- •11.Any condition or disorder other than heart failure that: Requires ongoing hospitalization for treatment, or - may limit life expectancy within 3 years, or - would not permit optimal participation in the trial, or - would increase the risk of participation to the subject (in the opinion of the investigator)
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