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 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
NCT ID:
NCT01273259
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old and ≤ 75 years old
* Chronic Obstructive Pulmonary Disease with FEVs/VC \< 70% (\*)
* Respiratory pulmonary hypertension with mean pulmonary arterial pressure ≥ 20 mmHg (\*) related to normal pulmonary capillar pressure assessed by catheterization of the right side of the heart (pulmonary capillary wedge pressure ≤12mmHg)
* PO2 ≤ 70 mmHg assessed by arterial gasometry at ease
* If oxygenotherapy then oxygenotherapy more than 6 months before pre-screening
* Written informed consent
(\*) Criteria assessed from last health check or the last exams for COPD diagnosis
Exclusion Criteria:
* clinical instability and/or respiratory exacerbation dangerous for catheterization
* Pregnancy (ßHCG \> 20 UI /l) or breastfeeding on going
* General corticotherapy \> 0,5 mg/kg/day prednisolon equivalent
* Hepatic insufficiency (TP \< 50%) or renal insufficiency (creatininemia \> 130 µmol/l) or diabetes mellitus type I or II (treated by oral antidiabetic or insulin)
* Left-heart failure (coronary heart disease and/or left valvulopathy)
* High level of prostatic specific antigen (PSA) (\> 7ng/ml)
* Cancer antecedent or treatment on going
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01273259
Study Brief:
Protocol Section:
NCT01273259