Pulmonary Arterial HypertensionNCT03683082
Oxygen Treatment and Pulmonary Arterial Hypertension
A study testing Oxygen supplementation in people with Pulmonary Arterial Hypertension, run by George Papanicolaou Hospital at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Arterial Hypertension
- What is being tested?
- Oxygen supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 5 Jun 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major contraindications for CPET conduction
- Not providing informed consent -
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
"G. Papanikolaou" General Hospital
Thessaloniki, 57010
Afroditi Boutou, MD, MSc, PhD, 00306946611433, afboutou@yahoo.com
About this study
Official title: 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)
- Conditions
- Pulmonary Arterial Hypertension
- Being tested
- Oxygen supplementation, Sham O2 (medical air)
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen supplementationDrug
40% FiO2 via Venturi mask
Sham O2 (medical air)Drug
Medical air supplementation via Venturi mask
| Study group | Role | What they receive |
|---|---|---|
| PAH patients | Active comparator | Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask Receives: Drug: Oxygen supplementation |
| PAH patients (crossover) | Sham comparator | Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask Receives: Drug: Sham O2 (medical air) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise duration
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
Measured: through study completion, an average of a year
Secondary outcomes (4)
Dyspnea
Maximum dyspnea assessed by Borg dyspnea scale, during steady state cardiopulmonary exercise testing
Measured: through study completion, an average of a year
cerebral oxygenated hemoglobin
minimum value of cerebral oxygenated hemoglobin during steady state cardiopulmonary exercise testing
Measured: through study completion, an average of a year
Cardiac output
maximum cardiac output during steady state cardiopulmonary exercise testing
Measured: through study completion an average of a year
Fatigue
Maximum fatigue as assessed by Borg fatigue scale, during steady state cardiopulmonary exercise testing
Measured: through study completion, an average of a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start5 Jun 2018
- Primary completion10 Jun 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- George Papanicolaou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Afroditi Boutou, George Papanicolaou Hospital
- Investigators
- Georgia Pitsiou, MD, Ass Prof, Study chair, "G. Papanikolaou" General Hospital, Thessaloniki, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03683082
- Sponsor's protocol ID
- 803/2018
- Status last verified
- Sep 2018
- First submitted
- 20 Sep 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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. 2023 May-Jun;29(3):221-229. doi: 10.1016/j.pulmoe.2021.06.006. Epub 2021 Jul 15.
PubMed 34274251Boutou 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.
PubMed 33957299
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Oxygen Supplementation Among Pulmonary Arterial Hypertension Patients
- ClinicalTrials.gov ID
- NCT03683082
- Acronym / sponsor ID
- 803/2018
- Conditions
- Pulmonary Arterial Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- George Papanicolaou HospitalUniversity, hospital or other
- Study start
- 5 Jun 2018 (actual)
- Primary completion
- 10 Jun 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PAH patients | Active comparator | Drug: Oxygen supplementationSupplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask |
| PAH patients (crossover) | Sham comparator | Drug: Sham O2 (medical air)Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Major contraindications for CPET conduction
- Not providing informed consent -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygen supplementation40% FiO2 via Venturi mask | Drug | PAH patients |
| Sham O2 (medical air)Medical air supplementation via Venturi mask | Drug | PAH patients (crossover) |
Primary outcome
Exercise duration
Time frame: through study completion, an average of a year
Exercise duration (minutes), while conducting steady state cardiopulmonary exercise testing until exhaustion
4 secondary outcomes
Dyspnea
Time frame: through study completion, an average of a year
cerebral oxygenated hemoglobin
Time frame: through study completion, an average of a year
Cardiac output
Time frame: through study completion an average of a year
Fatigue
Time frame: through study completion, an average of a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
- Derived from this study: PubMed 34274251Dipla 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.
- Derived from this study: PubMed 33957299Boutou 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgia Pitsiou, MD, Ass Prof study chair
"G. Papanikolaou" General Hospital, Thessaloniki, Greece
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen supplementation in people with Pulmonary Arterial Hypertension, run by George Papanicolaou Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Afroditi Boutou, MD, PhD, MSc (00306946611433, afboutou@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise duration (time frame: through study completion, an average of a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03683082, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018.