Oxygen Treatment and Pulmonary Arterial Hypertension

Not Applicable

• Conditions: Pulmonary Arterial Hypertension
• Interventions: Drug: Oxygen supplementation; Drug: Sham O2 (medical air)

• Registration Number: NCT03683082
• Lead Sponsor: George Papanicolaou Hospital

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-05
• Status Verified: 2018-09
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-21
• Last Update Submitted: 2018-09-21
• Study First Posted: 2018-09-25
• Last Update Posted: 2018-09-25
• Primary Completion: 2019-06-10
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PAH patients	Oxygen supplementation	Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask
PAH patients (crossover)	Sham O2 (medical air)	Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask

Primary Outcome Measures

Name	Time	Method
Exercise duration	through study completion, an average of a year	Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

"G. Papanikolaou" General Hospital; 🇬🇷 Thessaloníki, Greece