Oxygen Treatment and Pulmonary Arterial Hypertension

• ClinicalTrials.gov Identifier: NCT03683082
• Recruitment Status: Unknown
• First Posted: September 25, 2018
• Last Update Posted: September 25, 2018
• Sponsor: George Papanicolaou Hospital
• Information provided by (Responsible Party): Afroditi Boutou, George Papanicolaou Hospital

Tracking Information

• First Submitted Date: September 20, 2018
• First Posted Date: September 25, 2018
• Last Update Posted Date: September 25, 2018
• Actual Study Start Date: June 5, 2018
• Estimated Primary Completion Date: June 10, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 21, 2018)

Exercise duration [ Time Frame: through study completion, an average of a year ]

Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 21, 2018)

• Dyspnea [ Time Frame: through study completion, an average of a year ]
  Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
• cerebral oxygenated hemoglobin [ Time Frame: through study completion, an average of a year ]
  minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
• Cardiac output [ Time Frame: through study completion an average of a year ]
  maximum cardiac output during steady state cardiopulmonary exercise testing
• Fatigue [ Time Frame: through study completion, an average of a year ]
  Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Oxygen Treatment and Pulmonary Arterial Hypertension
• Official Title: Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
• 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 Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Pulmonary Arterial Hypertension

Intervention

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

Study Arms

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

Publications *

• 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. 2021 Jul 15:S2531-0437(21)00126-4. doi: 10.1016/j.pulmoe.2021.06.006. Online ahead of print.
• 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.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 21, 2018): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 30, 2019
• Estimated Primary Completion Date: June 10, 2019 (Final data collection date for primary outcome measure)

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 -

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Greece

Administrative Information

• NCT Number: NCT03683082
• Other Study ID Numbers: 803/2018
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Afroditi Boutou, George Papanicolaou Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: George Papanicolaou Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Georgia Pitsiou, MD, Ass Prof; "G. Papanikolaou" General Hospital, Thessaloniki, Greece

• PRS Account: George Papanicolaou Hospital
• Verification Date: September 2018