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

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)

Condition or disease	Intervention/treatment	Phase
Pulmonary Arterial Hypertension	Drug: Oxygen supplementation; Drug: Sham O2 (medical air)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
• Actual Study Start Date: June 5, 2018
• Estimated Primary Completion Date: June 10, 2019
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Exercise duration [ Time Frame: through study completion, an average of a year ]
   Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion

Secondary Outcome Measures :

1. Dyspnea [ Time Frame: through study completion, an average of a year ]
   Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
2. 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
3. Cardiac output [ Time Frame: through study completion an average of a year ]
   maximum cardiac output during steady state cardiopulmonary exercise testing
4. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Contacts

Contact: Afroditi Boutou, MD, PhD, MSc; 00306946611433; afboutou@yahoo.com

Locations

Greece

"G. Papanikolaou" General Hospital; Recruiting

Thessaloníki, Greece, 57010

Contact: Afroditi Boutou, MD, MSc, PhD 00306946611433 afboutou@yahoo.com

Sponsors and Collaborators

George Papanicolaou Hospital

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Afroditi Boutou, Consultant in Respiratory Medicine, George Papanicolaou Hospital
• ClinicalTrials.gov Identifier: NCT03683082
• Other Study ID Numbers: 803/2018
• First Posted: September 25, 2018
• Last Update Posted: September 25, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Additional relevant MeSH terms:

Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension; Vascular Diseases; Cardiovascular Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases