Clinical trial NCT03683082: Oxygen Treatment and Pulmonary Arterial Hypertension
Official title: Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: George Papanicolaou Hospital
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)


Eligibility criteria: 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 -

Primary outcomes:
measure: Exercise duration
timeFrame: through study completion, an average of a year
Secondary outcomes:
measure: Dyspnea
timeFrame: through study completion, an average of a year
measure: cerebral oxygenated hemoglobin
timeFrame: through study completion, an average of a year
measure: Cardiac output
timeFrame: through study completion an average of a year
measure: Fatigue
timeFrame: through study completion, an average of a year
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: "G. Papanikolaou" General Hospital
Study officials:
affiliation: "G. Papanikolaou" General Hospital, Thessaloniki, Greece
name: Georgia Pitsiou, MD, Ass Prof
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.