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 @ 2:41 AM
Ignite Modification Date:
2025-12-25 @ 2:41 AM
NCT ID:
NCT05977933
Eligibility Criteria:
Inclusion Criteria Study Aim 1:
* Subject referred for clinical assessment due to unexplained or worsening dyspnea and/or suspected Pulmonary Hypertension (PH).
* Subject is able and willing to provide appropriate Informed consent.
* Subject is greater than or equal to 21 years old
* Subject is not dependent on supplemental O2 to allow for CPET/sub-max-Shape exercise testing
* Subject is capable of performing a sub-max, incremental step exercise protocol, both physically and mentally, with no absolute contraindications to exercise testing, such as those causing symptoms or hemodynamic compromise Contraindications include syncope, active endocarditis, myocarditis or pericarditis, symptomatic severe aortic stenosis, uncontrolled heart failure (HF), uncontrolled cardiac arrhythmia, acute pulmonary embolus or pulmonary infarction, thrombosis of lower extremities, suspected dissecting aneurysm, uncontrolled asthma, pulmonary edema, respiratory failure, acute non-pulmonary disorder that may affect exercise performance or be aggravated by exercise such as infarction, renal failure or thyrotoxicosis, medical impairment with inability to cooperate with protocol instructions
Inclusion Criteria Study Aim 2:
* Subject must have been enrolled in Study Aim 1
* Dyspnea subject who has undergone echo examination and presented with suspicion of pulmonary arterial hypertension (PAH) category world health organization (WHO) I (mean pulmonary artery pressure (PAP) ≥ 20 mmHg; pulmonary vascular resistance (PVR) \> 2 WU and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg
Exclusion Criteria Study Aim 1:
* Resting Hypoxemia (oxygen saturation (Sp02) \<85%)
* The subject's mean arterial blood pressure is less than 70 mmHg despite fluid resuscitation and pressor therapy.
* The subject has positive pregnancy test (verified in a manner consistent with institution's standard of care)
* The subject has joint limitations to performing incremental exercise with gas exchange monitoring.
Exclusion Criteria Study Aim 2:
* Normal pulmonary hemodynamics on right heart Catheterization (RHC) ( mean pulmonary arterial pressure (mPAP) ≤ 20mmHG)
* RHC evidence of precapillary PH (mPAP \>20 mmHg, PAWP ≤15 mmHg, PVR \>2 WU) but has a diagnosis of group III, IV or V PH
* RHC evidence isolated postcapillary PH (mPAP \>20 mmHg, PAWP \>15 mmHg, PVR ≤2 WU) or combined pre- and postcapillary PH (mPAP \>20 mmHg, pulmonary arterial wedge pressure (PAWP) \>15 mmHg, PVR \>2 WU)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT05977933
Study Brief:
Protocol Section:
NCT05977933