EUCTR2006-006718-13-GB进行中（未招募）1 期
Opioids in the management of breathlessness in chronic heart failure
Hull and East Yorkshire NHS Trust0 个研究点目标入组 48 人开始时间: 2007年8月16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
- 48
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
- •Patients with:
- •Heart failure grade NYHA III/IV with Left Ventricular (LV) dysfunction confirmed by echocardiography.
- •Heart failure from any aetiology with stable NYHA status for at least one month.
- •Optimal (and unchanged over previous one month) medical management of their heart failure (diuretic and ACE inhibitor/AII antagonist).
- •Adequate renal clearance (GFR >30ml/min).
- •Aged 18 years or over.
- •Provided written informed consent and able to complete patient assessments.
- •An estimated survival of more than eight weeks.
- •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
- •Patients who:
- •Are unable to complete patient related information on entry.
- •Have significant co-existing lung disease (e.g. COPD, Asthma, Lung fibrosis) contributing significantly to the patients’ breathlessness.
- •Have significant renal impairment (GFR <=30ml/min).
- •Are unable to provide informed consent.
- •Have used morphine based medications for breathlessness within the last month.
- •Have known true morphine allergies.
- •Patients who have conditions contraindicated in the Summary of Product Characteristics (SmPCs) for Oramorph and Oxynorm, namely:
- •Respiratory depression, obstructive airways disease, acute and chronic bronchial asthma, cor pulmonale, hypercarbia, acute hepatic disease, moderate to severe hepatic impairment, acute alcoholism, acute abdomen, delayed gastric emptying, chronic constipation, head injury, coma, convulsive disorders, raised intracranial pressure, paralytic ileus, severe renal impairment, known hypersensitivity to product constituents and those receiving Mono-amine Oxidase inhibitors (MAOIs) or within 2 weeks of cessation of these drugs.
- •Patients who are planning to undergo a surgical or interventional procedure, those taking a medicinal product with a known interaction with opioid based compounds, and women who are pregnant or lactating will also be excluded.
- •Patients will be withdrawn from the study on:
- •Withdrawal of patient consent.
- •Withdrawal of the patient by the treating physician or medical researcher due to the patient no longer meeting the eligibility criteria.
研究者
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