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Pulmonary arterial hypertension (PAH) is a disease characterised with significant morbidity and poor prognosis. Dyspnoea and impaired exercise capacity are very common manifestations of the disease, and result in significant impairment of patients' quality of life. Although hypoxemia is common among subjects with PAH, published data on the effects of supplementary oxygen therapy on specific clinical outcomes among these patients are currently few, while the existing data on the potential benefits of oxygen supplementation to treat exercise-induced hypoxemia, in this patient population, are even more controversial. Based on the aforementioned, the purpose of this prospective, crossover clinical trial is to investigate the acute effects of supplemental oxygen administration on the: a) exercise capacity, b) severity of dyspnea, c) cerebral oxygenation, b) muscle oxygenation, and e) hemodynamic profile, as compared to delivery of medical air (sham oxygen), in a group of patients with PAH, during steady state cardiopulmonary exercise testing (CPET)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAH patients | Active Comparator | Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask |
|
| PAH patients (crossover) | Sham Comparator | Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen supplementation | Drug | 40% FiO2 via Venturi mask |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise duration | Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion | through study completion, an average of a year |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea | Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing | through study completion, an average of a year |
| cerebral oxygenated hemoglobin | minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Afroditi Boutou, MD, PhD, MSc | Contact | 00306946611433 | afboutou@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Georgia Pitsiou, MD, Ass Prof | "G. Papanikolaou" General Hospital, Thessaloniki, Greece | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "G. Papanikolaou" General Hospital | Recruiting | Thessaloniki | 57010 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34274251 | Derived | Dipla K, Boutou AK, Markopoulou A, Papadopoulos S, Kritikou S, Pitsiou G, Stanopoulos I, Kioumis I, Zafeiridis A. Differences in cerebral oxygenation during exercise in patients with idiopathic pulmonary fibrosis with and without exertional hypoxemia: does exercise intensity matter? Pulmonology. 2023 May-Jun;29(3):221-229. doi: 10.1016/j.pulmoe.2021.06.006. Epub 2021 Jul 15. | |
| 33957299 |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000388 | Air |
| ID | Term |
|---|---|
| D001272 | Atmosphere |
| D004777 | Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
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| Sham O2 (medical air) |
| Drug |
Medical air supplementation via Venturi mask |
|
| through study completion, an average of a year |
| Cardiac output | maximum cardiac output during steady state cardiopulmonary exercise testing | through study completion an average of a year |
| Fatigue | Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing | through study completion, an average of a year |
| Derived |
| Boutou AK, Dipla K, Zafeiridis A, Markopoulou A, Papadopoulos S, Kritikou S, Panagiotidou E, Stanopoulos I, Pitsiou G. A randomized placebo-control trial of the acute effects of oxygen supplementation on exercise hemodynamics, autonomic modulation, and brain oxygenation in patients with pulmonary hypertension. Respir Physiol Neurobiol. 2021 Aug;290:103677. doi: 10.1016/j.resp.2021.103677. Epub 2021 May 3. |
| D008685 |
| Meteorological Concepts |
| D004778 | Environment and Public Health |