EUCTR2004-000746-20-DE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 SA/NV0 个研究点目标入组 150 人开始时间: 2006年5月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
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
- •- Subjects is aged =40 years
- •- Symptoms of heart failure; a documented history of heart failure
- •- A left ventricular ejection fraction = 45% assessed by echocardiography, radionuclide ventriculography or magnetic resonance (MRI)
- •- NYHA functional class II or III
- •- 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
- •- 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
- •- The subject is unable to perform a 6 minutes walking test
- •- Planned invasive cardiac procedures carried out during the study e.g. 6 months after randomisation
- •- The subject had recently (< 3 months) unstable angina, acute myocardial infarction or stroke treated with a beta-blocker
- •- 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)
- •- The subject has concomitant diseases (COPD (FEV1 < 50%), peripheral arterial disease, orthopedic diseases) as the main cause of exercise impairment
- •- Presence of major contraindications to beta-blocker therapy, such as severe sinus bradycardia (<50 beats/min), atrio-ventricular block, bronchial asthma sensitive to beta-agonist agents, unstable heart failure, sick sinus syndrome including sino-atrial block, untreated pheochromocytoma, metabolic acidosis, hypotension and severe peripheral vascular disturbances.
- •- The subject is treated with verapamil or diltiazem
- •- The subject has a systolic blood pressure < 100 mmHg
- •- The subject is pregnant, or breast feeding, or of childbearing potential without using adequate contraception. Adequate methods of contraception are: hormonal contraception-oral, patch or progestagens injection-, vaginal ring, Intra-uterine device, all methods, which demonstrate a failure rate <1 %).
- •- The subject has a history of alcohol or other illicit drug abuse
- •- The subject suffers from any other medical condition that may exclude the patient for safety reasons or interfere with the objective of the study according to the investigator’s judgment
- •- The subject is expected to have a poor compliance to the study drug therapy
- •- The subject is participating in any other clinical trial with an investigational product, or the subject is scheduled to receive any such product during the study or in the 4 weeks following the study
- •- A left ventricular ejection fraction < 45% assessed by any one of the methods use during the study e.g. echocardiography, radionuclide ventriculography or magnetic resonance imaging (MRI)
- •- Uncontrolled arterial hypertension defined as >160/95 mmHg.
- •- Systolic cardiac insufficiency for which the treatment with beta blockers is indicated.
- •- Any significant alteration of the hepatic function defined as a 2 fold increase of transaminases.
- •- Hypersensitivity to NebiletÒ or its excipients
研究者
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