EUCTR2009-016096-29-GB进行中（未招募）不适用
Pilot of oral Sildenafil for the treatment of Pulmonary Hypertension in Thalassaemia with comparison to controls. - Pulmonary Hypertension (PHT)Study
niversity College London0 个研究点目标入组 24 人开始时间: 2010年3月17日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
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
- •INCLUSION CRITERIA
- •1) Alpha, beta or E-beta thalassaemia confirmed by Hb-electrophoresis or molecular diagnosis
- •2) Age at entry at least 16 years
- •Intervention:
- •1) Pulmonary hypertension defined as TRjet velocity by Doppler echocardiography greater than 2.5 m/s
- •1) Lack of pulmonary hypertension defined as TRjet velocity by Doppler echocardiography less than 2.5 m/s
- •Are the trial subjects under 18? yes
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •EXCLUSION CRITERIA
- •1) Pregnancy or lactation at baseline
- •2) Hypersensitivity to arginine or sildenafil based on prior use.
- •Any of the following medical conditions:
- •- Severe renal insufficiency defined as use of hemodialysis or serum creatinine greater than 2.5mg/dl at the time of screening.
- •- Cardiac disease with adjustment of cardiac medications within the last 60 days
- •- Symptomatic coronary artery disease as indicated by a history of chest pain, angina, claudication or surgery to treat coronary artery disease within the last year
- •- Stroke defined as a new focal neurological deficit lasting more than 24 hours within the last 45 days.
- •- New diagnosis of pulmonary embolism by ventilation-perfusion scan, angiography or any other technique within the last 90 days
- •- History of retinal detachment or retinal hemorrhage in the last 180 days
- •- Use of nitrate-based vasodilators, prostacyclin (inhaled, subcutaneous or intravenous), endothelin antagonists, or any other medication for pulmonary hypertension.
- •- Acute asthma exacerbation requiring use of prednisone within the last 60 days.
- •- Initiation or dosage increase of calcium channel blockers within the last 30 days.
- •- Initiation of any other cardiac or pulmonary medication within the last 90 days.
- •- Patients with a TRjet velocity of exactly 2.5 are not eligible for either group.
- •- Presence of any other condition, which in the opinion of the investigator, would make the patient unsuitable for enrollment or could interfere with the patient's compliance with the protocol, including but not limited to alcohol or drug abuse.
- •- No measurable TRjet on Doppler echocardiography (i.e. presence of PHT cannot be confirmed or ruled out).
- •- Inability or refusal to provide informed consent.
研究者
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