Oxygen Treatment and Pulmonary Arterial Hypertension

Pulmonary Arterial Hypertension Clinical Trial

Official title:

Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03683082
• Other study ID #: 803/2018
• Status: Recruiting
• Phase: N/A
• Start date: June 5, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: September 2018
• Source: George Papanicolaou Hospital
• Contact: Afroditi Boutou, MD, PhD, MSc
• Phone: 00306946611433
• Email: afboutou[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 30, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Pulmonary Arterial Hypertension

Intervention

Drug:
• Oxygen supplementation
40% FiO2 via Venturi mask
• Sham O2 (medical air)
Medical air supplementation via Venturi mask

Locations

Country	Name	City	State
Greece	"G. Papanikolaou" General Hospital	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
George Papanicolaou Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise duration	Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion	through study completion, an average of a year
Secondary	Dyspnea	Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing	through study completion, an average of a year
Secondary	cerebral oxygenated hemoglobin	minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing	through study completion, an average of a year
Secondary	Cardiac output	maximum cardiac output during steady state cardiopulmonary exercise testing	through study completion an average of a year
Secondary	Fatigue	Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing	through study completion, an average of a year