Diagnosis and Treatment Management of Pulmonary Arterial Hypertension from Submaximal Cardiopulmonary Exercise Testing
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-004520
About this study
The purpose of this study is to test submaximal exercise testing as a tool to improve early detection of Pulmonary Hypertension (PH) and provide an objective evidence-based measure of PH therapy efficacy that can be easily used in academic and community practices.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Adults referred for clinical assessment due to unexplained or worsening dyspnea and/or suspected Pulmonary Hypertension (PH).
- No absolute contraindications to exercise testing, such as uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
- Able and willing to provide written informed consent.
- Able and willing to perform submaximal incremental cardiopulmonary exercise test (SHAPE iCPET).
- For Aim 2 specifically, only those patients with right-heart catheterization diagnosis of Pulmonary Arterial Hypertension (PAH) will be recruited; that is, patients with evidence of pulmonary venous or post-capillary.
Exclusion Criteria:
- Resting SpO2 > 85%.
- Dependence upon supplemental O2 to allow performance of submaximal cardiopulmonary exercise test (SHAPE iCPET).
- Physician-determined unsuitability to undergo right-heart catheterization.
- Positive pregnancy test.
- Musculoskeletal or other conditions that would limit the performance of submaximal cardiopulmonary exercise testing.
- Comorbidities including syncope, active endocarditis, myocarditis, or pericarditis, uncontrolled heart failure, uncontrolled asthma, pulmonary edema, and any other disorder that may effect and/or be aggravated by exercise performance including myocardial ischemia, renal failure, or thyrotoxicosis.
For Aim 2:
- PH due to left-heart disease or with unclear/multifactorial mechanisms).
Eligibility last updated 4/29/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Bryan Taylor, Ph.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available