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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT01520493
Eligibility Criteria:
Inclusion Criteria:
* WHO functional class II-III idiopathic PAH patients;
* WHO functional class II-III PAH-SSc patients with hemodynamic assessment \<6 months;
* sedentary healthy subjects;
* subjects with limited SSc (without PAH) individually matched for age, gender, height and weight.
Exclusion Criteria:
1. unstable clinical condition (e.g. recent syncope, WHO functional class IV);
2. a six-minute walked distance \< 300 meters during routine follow-up at the pulmonary hypertension clinic;
3. left ventricular ejection fraction \< 40%;
4. restrictive (lung fibrosis on CT scan or total lung capacity \< 80% of predicted) or obstructive lung disease (FEV1/FVC \< 70%);
5. contraindication for MRI;
6. body mass index \> 30 kg/m2;
7. known locomotor abnormality.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT01520493
Study Brief:
Protocol Section:
NCT01520493