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 @ 4:50 PM
Ignite Modification Date:
2025-12-24 @ 4:50 PM
NCT ID:
NCT04732650
Eligibility Criteria:
1. Inclusion Criteria
* Age at least 18 years
* Patient who was scheduled to change Ambrisentan from Bosentan (prospective arm) or who already changed to Ambrisentan from Bosentan (retrospective arm)
* Presence of cyanosis with \< 95 % arterial oxygen saturation (measured by transcutaneous pulse oximetry) or documented during exercise test (6 minute walk distance test or CPT stress test)
* Bosentan treatment more than 3months before changing to Ambrisentan and stable medication dosage for 1 month before changing medication
* Presence of PAH as diagnosed by invasive methods with Rp:Rs \> 0.75 measured at rest or diagnosed by echocardiography with TR Vmax \> 3.5m/s and bidirectional or right to left shunt.
* One of the following diagnosis:
i) non-corrected large congenital shunting defect at atrial, ventricular or arterial level: Partial anomalous venous return, atrial septal defect, ventricular septal defect, atrioventricular cushion defect, persistent ductus arteriosus, or a combination of these.
ii) Surgically corrected shunting defect (diagnoses as above) with significant residual defect iii) Other diagnoses with univentricular physiology/haemodynamics.
2. Exclusion Criteria
* pregnancy or lactation
* women of child-bearing age who are sexually active without practicing 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)
* acute decompensated heart failure within 7 days before the invasive procedure
* significant anemia (Hb \< 9.0 g/dl)
* decompensated symptomatic polycythaemia
* significant impairment of hepatic function (Child Pugh class C)
* Significant left ventricular diseases (LV EF \< 45%)
* significant valvular diseases other than tricuspid or pulmonary regurgitation ( mitral or aortic valvular impairment more than moderate degree)
* pericardial constriction
* history of stroke, myocardial infarction or life-threatening arrhythmia within 6 months before screening
* bronchopulmonary dysplasia or other chronic severe lung diseases
* history of significant pulmonary embolism (in situ thromboembolism with optimal anticoagulation can be enrolled)
* other relevant diseases (e.g. HIV infection)
* trisomy 21
* Unstable medication, recent changes in dosage regimen
* Other medication with vascular action
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT04732650
Study Brief:
Protocol Section:
NCT04732650