EUCTR2004-004169-13-GB进行中(未招募)1 期
A Pilot study to assess the effects of beta-blockade on exercise capacity and BNP levels in patients with predominantly diastolic heart failure
south manchester university hospital nhs trust0 个研究点目标入组 40 人开始时间: 2005年4月21日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 40
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
- •All patients must satisfy all of the following criteria to be entered into the study.
- •1) Evidence or history of clinical heart failure.
- •2) Ejection fraction of >45%.
- •3) Raised Plasma BNP levels.
- •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) Clinical evidence of pulmonary or peripheral oedema.
- •2) History of asthma or significant reversible chronic obstructive airways disease (reversibility in FEV1 of > 15%)
- •3) Hypotension (BP < 100/60)
- •4) Significant bradycardia (heart rate < 55 bpm), 2nd or 3rd degree AV block.
- •5) History of intolerance to beta-blocker treatment.
- •6) Diagnosis of constrictive pericarditis.
- •7) Presence of severe peripheral vascular disease.
- •10) Myocardial infarction within 3 months prior to enrolment.
- •11) Female patients, who are pregnant, breast feeding or planning pregnancy during the course of the study.
- •12) Use of any investigational drug within 2 weeks of enrolment into the study.
- •13) Recent changes (less than 2 weeks) in cardiac medications other than that instituted by the investigators.
- •14) Significant co. morbid disease with a limited prognosis such that likely period of survival from the co morbidity is less than a year.
- •15) Clinically significant abnormality identified on screening history, physical examination, laboratory tests, ECG or Echocardiogram, which in the judgment of the investigator would preclude safe completion of the study.
- •16) An indication of beta-blocker treatment arises during the study.
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