Study of Dehydroepiandrosterone (DHEA) in Respiratory Pulmonary Hypertension in Adults. Phase 2 Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 4
- 主要终点
- Efficacy of DHEA on exercise capacity (six-minute walk test)
研究概览
简要总结
DHEA prevents and reverses chronic hypoxic pulmonary hypertension in a chronic hypoxic-pulmonary hypertension model in the rat. However, no study has been performed in human. The purpose of this study is to determine if DHEA is effective in the treatment of respiratory pulmonary hypertension in adults with Chronic Obstructive Pulmonary Disease (COPD) on exercise capacity and haemodynamic variables. Patients will receive after randomisation either 25 mg/day or 200mg/day oral DHEA over a one-year period. Evaluation concerns clinical parameters, echocardiography and right catheterization after and before treatment. Primary end-point is the six-minute walk test. This is a prospective double blind, randomised, placebo controlled study which will be realized in four university hospitals in France : Bordeaux, Strasbourg, Toulouse and Limoges.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old and ≤ 75 years old
- •Chronic Obstructive Pulmonary Disease with FEVs/VC < 70% (*)
- •Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmHg (*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
- •PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
- •If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
- •Written informed consent
- •(*) Criteria assessed from last health check or the last exams for COPD diagnosis
排除标准
- •clinical instability and/or respiratory exacerbation dangerous for catheterization
- •Pregnancy (ßHCG > 20 UI /l) or breastfeeding on going
- •General corticotherapy > 0,5 mg/kg/day prednisolon equivalent
- •Hepatic insufficiency (TP < 50%) or renal insufficiency (creatininemia > 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
- •Left-heart failure (coronary heart disease and/or left valvulopathy)
- •High level of prostatic specific antigen (PSA) (> 7ng/ml)
- •Cancer antecedent or treatment on going
研究组 & 干预措施
200 mg /day arm
干预措施: DHEA Treatment (Drug)
25 mg/day arm
干预措施: DHEA Treatment (Drug)
结局指标
主要结局
Efficacy of DHEA on exercise capacity (six-minute walk test)
时间窗: inclusion and one year of treatment
次要结局
- Pulmonary and systemic arterial pressures (mean, systolic and diastolic)(Inclusion and after one year of treatment)
- Pulmonary vascular resistances(Inclusion and after one year of treatment)
- Safety / Compliance(along one year of treatment)