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 @ 1:46 AM
Ignite Modification Date:
2025-12-25 @ 1:46 AM
NCT ID:
NCT02253394
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily gives informed consent to participate in the study.
2. Right heart catheterization demonstrating conventional mean pulmonary artery pressure (mPAP) \>25, pulmonary vascular resistance (PVR) \>3.0 Wood Units, pulmonary capillary wedge pressure (PCWP) \<16 mmHg within two years of enrollment
3. Subject is 18 years of age or older at Screening.
4. Diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with Connective Tissue Disease (CTD), PAH associated with repaired/unrepaired congenital systemic-to-pulmonary shunt, Portopulmonary hypertension or PAH associated with HIV infection.
5. New York Heart Association Functional Class II or III
6. Stable therapy with ambrisentan 5 or 10 mg every day for \> 90 days.
7. Baseline 6-Minute Walk Distance 50-450m
Exclusion Criteria:
1. Substantial Primary Lung disease
* forced expiratory volume at one second (FEV-1)/forced vital capacity (FVC) \<0.6 and FEV-1 \<70% predicted
* diffusing capacity of lung for carbon monoxide (DLCO) \<30% predicted
* Pulmonary fibrosis
2. Left ventricular ejection fraction \< 50%
3. Pulmonary capillary wedge pressure \> 16 mm Hg
4. Aortic valve disease
5. Ischemic heart disease
6. Systemic hypotension (SBP \<90 mm Hg)
7. Co-existing treatment with other endothelin receptor antagonists or prostacyclin analogues
8. New York Heart Association Functional Class IV
9. Chronic thromboembolic pulmonary hypertension
10. Known or suspected pulmonary veno-occlusive disease
11. Serum creatinine \>2.0 mg/dL in women, Serum creatinine \>2.5 mg/dL in men
12. Baseline serum potassium \>5.0 milliequivalent (mEq)/L
13. Participation in ongoing drug/intervention-based clinical trial
14. Pregnancy
15. Unable to provide consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02253394
Study Brief:
Protocol Section:
NCT02253394