Status:
COMPLETED
Bosentan for Mild Pulmonary Vascular Disease in Asd Patients.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Heart Septal Defects, Atrial
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Volume overload due to left-to-right shunting in patients with atrial septal defect type secundum causes pulmonary vascular disease over a long period of time. Pulmonary vascular resistance can be ass...
Detailed Description
1. INTRODUCTION AND RATIONALE 1.1 MEDICAL BACKGROUND Atrial septal defect (ASD) represents approximately 10% of all congenital heart diseases and is the third most common form of congenital he...
Eligibility Criteria
Inclusion
- Signed informed consent by patient prior to initiation of any study-mandated procedure.
- Male or female patients \> 40 years with atrial septal defect type secundum and \> 40 years of age 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.
- Women not of childbearing potential are defined as postmenopausal (amenorrhea for at least 1 year), or documented surgically or naturally sterile.
Exclusion
- Pregnancy or lactation
- Women of child-bearing age who are sexually active without practising reliable methods of contraception
- Any disease or impairment that, in the opinion of the investigator, excludes a subject from participation
- Substance abuse (alcohol, medicines, drugs)
- 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
- Insufficient compliance
- Subjects who are not able to perform cardiopulmonary exercise testing
- ASD repair \< 6 months before inclusion
- PAH of any aetiology other than the one specified in the inclusion criteria
- Impairment of organic function (renal, hepatic)
- Arterial hypotension (systolic blood pressure \< 85 mmHg)
- Anaemia (Hb\< 10 g/dl)
- Decompensated symptomatic polycythemia
- Thrombocytopenia (\< 50000/µl)
- Significant valvular diseases, other than tricuspid or pulmonary regurgitation
- Chronic lung disease or total lung capacity \< 80% of predicted value
- History of significant pulmonary embolism
- Other relevant diseases (HIV infection, Hep B/C infection)
- Subjects with known intolerance to bosentan or their constituents
- 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 opinion, may interfere with bosentan treatment.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01218607
Start Date
October 1 2010
End Date
March 1 2014
Last Update
March 5 2014
Active Locations (1)
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1
University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000