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 @ 12:10 AM
Ignite Modification Date:
2025-12-25 @ 12:10 AM
NCT ID:
NCT02958358
Eligibility Criteria:
Inclusion Criteria:
1. Subject is male or female aged \> or =18 years of age and \< or =70 years.
2. Subject is diagnosed with pulmonary arterial hypertension (WHO Group I, by right heart catheterization (RHC), mean PA pressure \> 25 and PCWP \< 15) and planning to start therapy with ambrisentan, either as de-novo monotherapy or as part of combination therapy.
3. Subject has most recently undergone RHC within three months of entering the study.
4. If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least three months.
5. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
6. A signed and dated written informed consent is obtained from the subject.
7. Available to complete the study.
8. Able to fast for 6 hours prior to the study.
9. Able to lie flat and able to perform a 30 second breath hold.
Exclusion Criteria:
1. FEV1 and/or TLC \< 70% predicted.
2. PCWP \> 15 mm Hg.
3. Inability to perform the study (by primary MD or investigator assessment).
4. The subject is unable to perform the respiratory maneuvers necessary for the exam.
5. Subjects who have diabetes mellitus or glucose intolerance.
6. Subjects who have a known contraindication to ambrisentan.
7. Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study.
8. The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
9. The subject is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test.
10. Subject with clinical instability in the judgment of the investigator, or hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
11. Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, or COPD.
12. Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
13. The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02958358
Study Brief:
Protocol Section:
NCT02958358