Pulmonary Arterial Hypertension
Conditions
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)
Interventions
40% FiO2 via Venturi mask
DRUGSham O2 (medical air)
Medical air supplementation via Venturi mask
Sponsors
George Papanicolaou Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Group I PAH patients 2. Stable disease (no hospitalisation, disease deterioration or change in regular PAH medication during the last month) 3. Presence of exercise-induced hypoxemia
Exclusion criteria
1. Major contraindications for CPET conduction 2. Not providing informed consent -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exercise duration | through study completion, an average of a year | Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea | through study completion, an average of a year | Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing |
| cerebral oxygenated hemoglobin | through study completion, an average of a year | minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing |
| Cardiac output | through study completion an average of a year | maximum cardiac output during steady state cardiopulmonary exercise testing |
| Fatigue | through study completion, an average of a year | Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing |
Countries
Greece
Contacts
Primary ContactAfroditi Boutou, MD, PhD, MSc
Outcome results
None listed