Oxygen Treatment and Pulmonary Arterial Hypertension

September 21, 2018 updated by: Afroditi Boutou, George Papanicolaou Hospital

Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 57010
        • Recruiting
        • "G. Papanikolaou" General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise duration
Time Frame: through study completion, an average of a year
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
through study completion, an average of a year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dyspnea
Time Frame: through study completion, an average of a year
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
through study completion, an average of a year
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
through study completion, an average of a year
Cardiac output
Time Frame: through study completion an average of a year
maximum cardiac output during steady state cardiopulmonary exercise testing
through study completion an average of a year
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
through study completion, an average of a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Papanicolaou Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2018

Primary Completion (Anticipated)

June 10, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

September 25, 2018

Study Record Updates

Last Update Posted (Actual)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 21, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 803/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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