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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT05523557
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years;
* New York Health Association (NYHA) II-III functional class;
* PAH or CTEPH diagnosed by right heart catheterization, evidencing: mean pulmonary arterial pressure (PAPm) ≥25 mmHg; pulmonary wedge pressure (PCWP) ≤15 mmHg; and pulmonary vascular resistance (PVR) ≥240 din/s/cm5 or 3 woods unit (WU);
* Patients with optimized PH targeted treatment, including intensified diuretic treatment and who have remained stable for at least 2 months before entering the study (no changes in medical treatment are expected throughout the 12-week study period);
* Patients who already finished a 3-months rehabilitation program;
* Be able to understand and be willing to sign the informed consent form.
Exclusion Criteria:
* Patients with other forms of PH (groups 2, 3 or 5);
* Pregnancy;
* Patients with signs of right heart decompensation;
* Inability to exercise on a cycle ergometer or walking;
* Acute infection or fever;
* Any change in the treatment of the disease in the last 2 months;
* Acute ischemic heart disease, unstable angina pectoris, exercise-induced ventricular arrhythmias, decompensated heart failure;
* History or suspicion of inability to cooperate properly in the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05523557
Study Brief:
Protocol Section:
NCT05523557