BOsentan for Mild Pulmonary vascular disease in Asd patients (the BOMPA trial): a double-blind, randomized controlled, pilot trial - BOMPA trial

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Specific
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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