Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT01827059
Eligibility Criteria:
Inclusion Criteria:
* adult (\>18 years) and mentally competent
* Open or closed septal defect (ASD I/II, VSD, AVSD)
* Open or closed systemic-to-pulmonary shunt (PDA, PAPVC)
* Negative pregnancy test
* Presence of X-PAH
* One of the following criteria, at peak exercise.
* mPAP \> 34 mmHg with CO ≤ 10 l/min
* mPAP \> 40 mmHg with CO ≤ 15 l/min
* mPAP \> 45 mmHg with CO ≤ 20 l/min
* mPAP \> 50 mmHg with CO ≤ 30 l/min
* a PVR (slope pressure/flow plot) of \> 3 mmHg/l/min
Exclusion Criteria:
* Incapable of giving informed consent
* Pregnancy or lactation (a pregnancy test is offered to every female patient within fertile age)
* Women of child-bearing age who are sexually active without practising reliable methods of contraception. The use of oral contraceptives only, is not considered reliable. Reliable methods include concomitant use of oral contraceptives and condoms ("Double Dutch"), and those methods with a less than 1% chance of pregnancy during typical use20, including intrauterine contraceptives (Copper T, Mirena), Implanon, and sterilization.
* Substance abuse (alcohol, medicines, drugs)
* Subjects who are not able to perform cardiopulmonary exercise testing
* Any cardiac operation \< 6 months before inclusion
* PAH of any aetiology other than the one specified in the inclusion criteria
* Left ventricular ejection fraction \< 30%
* Significant impairment of renal function (GFR \< 30 ml/min/1.73m2)
* Moderate to severe liver disease: Child Pugh class B or C
* Raised plasma transaminases level \> three times upper normal limit
* Arterial hypotension (systolic blood pressure \< 85mmHg)
* Anaemia (Hb \< 10g/L, or \<6.21 mmol/L)
* Significant valvular disease, other than tricuspid or pulmonary regurgitation
* Chronic lung disease or total lung capacity \< 80% 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 inclusion
* Unspecified or other significant medication (glibenclamide or immunosuppression)
* PAH therapy (endothelin receptor antagonists, PDE-5 inhibitors, prostanoids)
* Medication which is not compatible with bosentan or interferes with its metabolism (inhibitors or inducers of CYP2C9, CYP3A4) or medication which may interfere with bosentan treatment according to the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01827059
Study Brief:
Protocol Section:
NCT01827059