Status:
NOT_YET_RECRUITING
Assessing the Utility of Submaximal CPET in Treatment Management of PAH
Lead Sponsor:
Shape Medical Systems, Inc.
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
21+ years
Brief Summary
Pulmonary hypertension (PH) is associated with worsening breathlessness and exercise capacity, right-heart failure, and adverse outcomes including increased mortality. Moreover, PH disease progression...
Detailed Description
Pulmonary hypertension (PH) is a devastating disease characterized by progressive dyspnea/exercise intolerance, right-heart failure, and carries a high risk of morbidity and early mortality. PH diseas...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
April 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT05977933
Start Date
April 1 2024
End Date
December 30 2024
Last Update
March 13 2024
Active Locations (6)
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1
Harbor-UCLA Medical Center
Torrance, California, United States, 90502-2006
2
National Jewish Health
Denver, Colorado, United States, 80206-2761
3
Mayo Clinic
Jacksonville, Florida, United States, 32224-1865
4
WellStar Health System
Atlanta, Georgia, United States, 30312-1213