ISRCTN15915491已完成未知
A single-centre, placebo-controlled, double-blinded, randomized, crossover study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome
Royal Brompton & Harefield NHS Trust0 个研究点目标入组 15 人开始时间: 2015年2月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients > 18 years
- •2. Body weight > 40 kg
- •3. Functional class III (1998 WHO classification)
- •4. Patients with documented oxygen saturation < 90%, at rest or during exercise with room air
- •5. Patients with established pulmonary hypertension related to congenital heart disease and post – tricuspid lesion able to perform a 6minute
- •walk test with latest walking distance < 400m or deterioration of 30m within 1 Year on dual oral therapy or patient not tolerating oral therapy
- •6. Patients stable for at least 3 months prior to screening
- •7. Patients providing written informed consent
排除标准
- •1. Pregnant patients
- •2. Trisomy 21
- •3. Obstructive lung disease (FEV1/FVC<60%)
- •4. Patients with systolic blood pressure <90 mm Hg
- •5. Patients with other conditions that may affect the ability to perform a six minute walk test
- •6. Patients unable to provide informed consent and comply with the protocol
- •7. Patients with known coronary artery disease
- •8. Patients who have started or stopped specific treatment for PAH within one month of screening, excluding anticoagulation
- •9. Patients active on an organ transplant list
- •10.Patients taking other investigational drugs/devices
- •11. Patients taking other Prostacyclin analogues, like Epoprostenol or Treprostinil
- •12. Patients with planned surgical intervention during the study period
- •13. Patients with HIV
研究者
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A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndromePulmonary Arterial Hypertension Eisenmenger syndromeMedDRA version: 17.0Level: LLTClassification code 10037405Term: Pulmonary hypertension primarySystem Organ Class: 100000004855MedDRA version: 17.0Level: LLTClassification code 10037406Term: Pulmonary hypertension secondarySystem Organ Class: 100000004855EUCTR2014-000091-25-GBRoyal Brompton and Harefield NHS Foundation Trust15
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