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Oxygen Treatment and Pulmonary Arterial Hypertension

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

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

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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


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




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



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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 -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683082


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

Locations
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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
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Study Chair: Georgia Pitsiou, MD, Ass Prof "G. Papanikolaou" General Hospital, Thessaloniki, Greece
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pulmonary Arterial Hypertension
Familial Primary Pulmonary Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases