EUCTR2004-000746-20-PT进行中（未招募）不适用
Effects Of The Long-Term Administration Of Nebivolol On The Clinical Symptoms, Exercise Capacity And Left Ventricular Function Of The Patients With Diastolic Dysfunction (ELANDD) - ELANDD
Menarini Benelux S.A/N.V.0 个研究点目标入组 180 人开始时间: 2006年6月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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)The subject is aged =40 years
- •2a) Symptoms of heart failure; a documented history of heart failure
- •3a) A left ventricular ejection fraction = 45% assessed by echocardiography, radionuclide ventriculography or magnetic resonance (MRI)
- •4a) NYHA functional class II or III
- •6a) The subject has given written informed consent for participation in the study. The subject is able and willing to visit the hospital for the planned study visits
- •10) Any diastolic abnormality well documented on echocardiography following the diagnostic criteria for diastolic heart failure published by the 'European Study Group on Diastolic Heart Failure'
- •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. The subject is unable to perform a 6 minutes walking test
- •3. Planned invasive cardiac procedures carried out during the study e.g. 6 months after randomization
- •4. The subject had recently (< 3 months) unstable angina, acute myocardial infarction or stroke treated with a beta blocker
- •5. The subject has exercise induced myocardial ischemia as a main cause of exercise impairment as shown by limiting symptoms (angina) or by the previous exams (exercise test, exercise echocardiography or myocardial scintigraphy)
- •6. The subject has concomitant diseases (COPD, peripheral arterial disease, orthopedic diseases) as the main cause of exercise impairment
- •7. Presence of major contraindications to beta-blocker therapy: severe sinus bradycardia (<50 beats/min), atrio-ventricular block, bronchial asthma sensitive to beta-agonist agents
- •8. The subject is treated with verapamil or diltiazem
- •9. The subject has a systolic blood pressure < 100 mmHg
- •10a. The subject is pregnant, or breast feading, or of childbearing potential without using adequate contraception.
- •11. The subject has a history of alcohol or other illicit drug abuse
- •12a. The subject suffers from any other medical condition that may interfere with the objective of the study according to the investigator's judgment.
- •13a. The subject is expected to have a poor compliance to drug therapy.
- •14a. The subject is participating in any other clinical trial with an investigational product, or the subject is scheduled to recieve any such product during the study or in the 4 weeks following the study.
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