Oxygen Treatment and Pulmonary Arterial Hypertension

Study Overview
=================
Brief Summary
-----------------
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)

Official Title
-----------------
Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Oxygen supplementation
* Drug: Sham O2 (medical air)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group I PAH patients Stable disease (no hospitalisation, disease deterioration or change in regular PAH medication during the last month) Presence of exercise-induced hypoxemia Exclusion Criteria: Major contraindications for CPET conduction Not providing informed consent -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PAH patients<br>Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask | Drug: Oxygen supplementation<br>* 40% FiO2 via Venturi mask<br>|
| Sham Comparator: PAH patients (crossover)<br>Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask | Drug: Sham O2 (medical air)<br>* Medical air supplementation via Venturi mask<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |