EUCTR2010-020209-33-BE进行中（未招募）1 期
BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial - BOMPA trial
niversity Hospitals Leuven0 个研究点目标入组 20 人开始时间: 2010年4月26日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •Signed informed consent by patient prior to initiation of any study-mandated procedure.
- •Male or female patients older than 40 years of age AND older than 40 years at the time of repair
- •Women of childbearing potential must have a negative pre-treatment pregnancy test and must use a reliable method of contraception during study treatment and for at least 3 months after study treatment termination.
- •Reliable methods of contraception are
- •Barrier type devices (female condom, diaphragm, contraceptive sponge) only in combination with a spermicide.
- •Intra-uterine devices
- •Hormone-based contraceptives.
- •Abstinention, rhythm method, and contraception by the partner alone are not considered as reliable methods for contraception
- •Women not of childbearing potential are defined as postmenopausal (amenorrhea for at least 1 year), or documented surgically or naturally sterile.
- •Presence of mild pulmonary vascular disease
- •Slope of right ventricular systolic pressure and cardiac output greater than 4.5 mmHg/L/min
- •Right ventricular systolic pressure greater than 40 mmHg at rest
- •Are the trial subjects under 18? no
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non-specific
- •o Pregnancy or lactation
- •o Women of child-bearing age who are sexually active without practising reliable methods of contraception
- •o Any disease or impairment that, in the opinion of the investigator, excludes a subject from participation
- •o Substance abuse (alcohol, medicines, drugs)
- •o Other medical, psychological or social circumstances that would adversely affect a patient’s ability to participate adequately in the study or increase the risk to the patient or others in the case of participation
- •o Insufficient compliance
- •o Subjects who are not able to perform cardiopulmonary exercise testing
- •o ASD repair < 6 months before inclusion
- •o PAH of any aetiology other than the one specified in the inclusion criteria
- •o Impairment of organic function (renal, hepatic)
- •o Arterial hypotension (systolic blood pressure < 85 mmHg)
- •o Anaemia (Hb< 10 g/dl)
- •o Decompensated symptomatic polycythemia
- •o Thrombocytopenia (< 50000/µl)
- •o Significant valvular diseases, other than tricuspid or pulmonary regurgitation
- •o Chronic lung disease or total lung capacity < 80% of predicted value
- •o History of significant pulmonary embolism
- •o Other relevant diseases (HIV infection, Hep B/C infection)
- •o Subjects with known intolerance to bosentan or their constituents
- •o Prohibited medication: any medication listed below which has not been discontinued at least 30 days prior to screening
- •? Unspecified or other significant medication (glyburide or immunosuppression)
- •? Drugs to treat PAH (endothelin receptor antagonists, PDE-5 antagonists, prostanoids)
- •? Medication that is not compatible with bosentan or that interferes with its metabolism (inhibitors of CYP2C9 or CYP3A4) or that, in the investigator’s opninion, may interfere with bosentan treatment.
研究者
相似试验
已完成
3 期
Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.Heart Septal Defects, AtrialNCT01218607Universitaire Ziekenhuizen KU Leuven10
招募中
2 期
Bosentan and Sildenafil in Pulmonary Hypertension in Cardiac AnesthesiaPACTR202209903019732Mansoura university40
进行中（未招募）
不适用
Bosentan use in interstitial lung disease (open label). Long-term open-label study in patients with interstitial lung disease associated with systemic sclerosis who completed the protocol AC-052-330/BUILD 2.Interstitial lung disease associated with systemic sclerosisEUCTR2004-000631-28-ITACTELION PHARMACEUTICALS ITALIA
已完成
不适用
Bosentan and Pulmonary Endothelial FunctionPulmonary Arterial HypertensionNCT01721564Prof David S Celermajer8
进行中（未招募）
不适用
A prospective clinical trial examining the effects of bosentan, a drug used for vascular dysfunction, on patients with liver cirrhosis and hepatopulmonary syndrome, wich is characterized by shortness of breath and hypoxemia (low oxygen levels in the blood of the arteries) caused by vascular abnormalities in the lungs of patients with liver disease.HPS is by far the most frequent respiratory complication of cirrhosis leading to significantly increased mortality. The only therapeutic option is liver transplantation. Many patients with HPS who are screened for liver transplantation are not listed for transplantation due to several reasons. Therefore, an effective medical treatment of HPS would be of central importance and may revolutionise the management in this frequent syndrome.EUCTR2010-023366-49-ATMed. Univ. Wien, Univ. Klinikum für Interne Medizin III18