EUCTR2014-002305-38-GB进行中（未招募）1 期
Does allopurinol reduce right ventricular mass in lung disease associated pulmonary hypertension? - The ALPHA Trial
niversity of Dundee/ NHS Tayside0 个研究点目标入组 72 人开始时间: 2014年12月24日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
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
入选标准
- •participant is willing and able to give informed consent
- •are aged 18 years or over
- •previously diagnosed with COPD or ILD
- •screening echocardiography based diagnosis of PH and/or RVH (RVSP>25mmHg, and/or PAT <110ms-2 and/or RVM >5.5mm)
- •stable lung disease medication for at least two weeks prior to consent
- •- women of child bearing potential must agree to shceduled pregnancy testing prior to and during study treatment period and to use an appropraite method of contraception if sexually active
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 36
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •- patients who are uinable to give informed consent
- •documented intolerance or allergy to allopurinol
- •- objection to taking capsules made from animal sourced gelatine
- •left Ventricular Ejection Fraction <45% on echocardiography screening
- •severe aortic stenosis on echocardiography screening
- •already had gout or currently taking allopurinol
- •severe hepatic disease
- •renal disease; CKD class 3B or greater
- •taking prohibited medication:azathioprine, 6 mercaptopurine, or theophylline
- •malignancy (receiving active treatment) or other life threatening diseases
- •pregnant or lactating
- •any contraindication to MRI (claustrophobia, metal implants)
- •patients who have participated in any other clinical trial of an investigational medicinal product within the previous 30 days will be excluded
- •women unwilling to agreet to use an appropriate method of contraception during the study treatment period if sexually active
- •any other considered by a study physician to be inappropriate for inclusion
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