Oxygen Treatment and Pulmonary Arterial Hypertension
Primary Purpose
Pulmonary Arterial Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Oxygen supplementation
Sham O2 (medical air)
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Arterial Hypertension
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 -
Sites / Locations
- "G. Papanikolaou" General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
PAH patients
PAH patients (crossover)
Arm Description
Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask
Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask
Outcomes
Primary Outcome Measures
Exercise duration
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
Secondary Outcome Measures
Dyspnea
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
cerebral oxygenated hemoglobin
minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
Cardiac output
maximum cardiac output during steady state cardiopulmonary exercise testing
Fatigue
Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing
Full Information
NCT ID
NCT03683082
First Posted
September 20, 2018
Last Updated
September 21, 2018
Sponsor
George Papanicolaou Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03683082
Brief Title
Oxygen Treatment and Pulmonary Arterial Hypertension
Official Title
Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 5, 2018 (Actual)
Primary Completion Date
June 10, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
George Papanicolaou Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Arterial Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PAH patients
Arm Type
Active Comparator
Arm Description
Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask
Arm Title
PAH patients (crossover)
Arm Type
Sham Comparator
Arm Description
Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask
Intervention Type
Drug
Intervention Name(s)
Oxygen supplementation
Intervention Description
40% FiO2 via Venturi mask
Intervention Type
Drug
Intervention Name(s)
Sham O2 (medical air)
Intervention Description
Medical air supplementation via Venturi mask
Primary Outcome Measure Information:
Title
Exercise duration
Description
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
Time Frame
through study completion, an average of a year
Secondary Outcome Measure Information:
Title
Dyspnea
Description
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
Time Frame
through study completion, an average of a year
Title
cerebral oxygenated hemoglobin
Description
minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
Time Frame
through study completion, an average of a year
Title
Cardiac output
Description
maximum cardiac output during steady state cardiopulmonary exercise testing
Time Frame
through study completion an average of a year
Title
Fatigue
Description
Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing
Time Frame
through study completion, an average of a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afroditi Boutou, MD, PhD, MSc
Phone
00306946611433
Email
afboutou@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georgia Pitsiou, MD, Ass Prof
Organizational Affiliation
"G. Papanikolaou" General Hospital, Thessaloniki, Greece
Official's Role
Study Chair
Facility Information:
Facility Name
"G. Papanikolaou" General Hospital
City
Thessaloníki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afroditi Boutou, MD, MSc, PhD
Phone
00306946611433
Email
afboutou@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34274251
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.
Results Reference
derived
PubMed Identifier
33957299
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.
Results Reference
derived
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Oxygen Treatment and Pulmonary Arterial Hypertension
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