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 @ 2:35 AM
Ignite Modification Date:
2025-12-25 @ 2:35 AM
NCT ID:
NCT02220634
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old
2. Diagnosis of RHC-proven PH
* Mean pulmonary artery pressure (mPAP) \> 25 mmHg
* Pulmonary vascular resistance (PVR) \> 3 woods units
* Pulmonary capillary wedge pressure (PCWP) \< 15 mmHg).
Exclusion Criteria:
1. Second- or third-degree AV block or sinus node dysfunction
2. Known hypersensitivity to adenosine or regadenoson
3. Systolic blood pressure \< 90mm Hg
4. Active bronchospasm
5. Autonomic dysfunction as defined by prior diagnosis of:
* Postural Orthostatic Tachycardia Syndrome (POTS)
* Neurocardiogenic Syncope (NCS)
* Neurally Mediated Hypotension (NMH)
* Vasovagal Syncope
6. Hypovolemia
7. \> 40% Left main coronary stenosis
8. Moderate or \> valvular stenosis
9. Pericarditis/pericardial effusions
10. \> 70% carotid artery stenosis
11. Positive urine pregnancy test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02220634
Study Brief:
Protocol Section:
NCT02220634