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 @ 8:03 PM
Ignite Modification Date:
2025-12-24 @ 8:03 PM
NCT ID:
NCT04004104
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of moderate HPS (defined by liver disease, hypoxemia \[PaO2 \< 80 mmHg and AaDo2 (alveolar-arterial PO2 difference) ≥ 15 mmHg or ≥ 20 mmHg if age \> 64 years\] and IPVD (intrapulmonary vasodilatations) as shown by contrast echocardiography\])
2. Presence of orthodeoxia (PaO2 decrease by \>4 mmHg when patient moves from supine to upright position).
Exclusion Criteria:
1. Pulmonary hypertension (echocardiographic estimated right ventricular systolic pressure \>/=50 mmHg and/or right heart catheterization mean pulmonary artery pressure \>25 mmHg with pulmonary capillary wedge pressure \</= 15 mmHg);
2. Significant obstructive ventilatory impairment (FEV1/FVC ratio \< 0.65) (FEV=forced expiratory volume in 1 second; FVC=forced vital capacity)
3. Known significant coronary artery disease;
4. Significant neurologic, orthopedic or rheumatological disorders preventing the use of a cycle ergometer;
5. Other absolute contraindications to submaximal tests (uncontrolled cardiac arrhythmia with hemodynamic compromise, symptomatic severe aortic stenosis, decompensated heart failure and acute cardiopulmonary illness);
6. Moderate or severe ascites.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04004104
Study Brief:
Protocol Section:
NCT04004104