EUCTR2014-000091-25-GB进行中（未招募）1 期
A single-centre, placebo-controlled, double-blinded, randomized, cross-over study of Iloprost (Ventavis®) in patients with Eisenmenger syndrome - Iloprost in patients with Eisenmenger Syndrome
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
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 6-minute 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
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
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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