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 @ 5:07 PM
Ignite Modification Date:
2025-12-24 @ 5:07 PM
NCT ID:
NCT06258850
Eligibility Criteria:
Inclusion Criteria:
1. Male and female patients aged 18 -75 years.
2. Patients with diagnosis of PAH of the following types according to 2022 ERS/ESC guidelines: idiopathic, hereditary, drug and toxin-induced PAH or associated to connective tissues disease.
3. Patients who are stable and treated with standard medications for PAH on monotherapy or with combinations of drugs, including calcium channel blockers, phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERA), prostacyclin analogues or selexipag or with stable dose of diuretics who had no treatment modification for at least 6 weeks before randomization.
4. Patients with an intermediate-low and intermediate-high risk score according to 2022 ERS/ESC guidelines.
5. Patients with severe deficiency of vitamin D, defined herein as plasma or serum 25(OH)vitamin D levels equal to or lower than 12 ng/ml
6. Patients who can understand and follow instructions, and who are able to participate in the study for the entire study.
7. Patients must have given their written informed consent to participate in the study after having received adequate previous information and before any study-specific procedures.
Exclusion Criteria:
1. Participation in another interventional clinical study within 30 days before screening.
2. Previous randomisation to treatment during this study (no re-randomisation).
3. Pregnant women or breastfeeding women, or women with childbearing potential not using a effective contraception method throughout the study.
4. Patients with a medical disorder, condition, or history of such that would impair the patient's ability to participate in or complete this study, in the opinion of the investigator.
5. Patients with substance abuse (eg, alcohol or drug abuse) within the previous 3 months before and at randomisation.
6. Patients with underlying medical disorders with an anticipated life expectancy \<2 years.
7. Patients with a history of severe allergies or multiple drug allergies or with hypersensitivity to the investigational drug or any of the excipients.
8. Patients unable to perform a valid 6MWD test (eg, orthopaedic disease or peripheral artery occlusive disease that affects the patient's ability to walk).
9. Excluded medication/treatment: active treatment with digoxin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06258850
Study Brief:
Protocol Section:
NCT06258850