NCT03683082

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2019

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
Last Updated

September 25, 2018

Status Verified

September 1, 2018

Enrollment Period

1 year

First QC Date

September 20, 2018

Last Update Submit

September 21, 2018

Conditions

Pulmonary Arterial Hypertension

Outcome Measures

Primary Outcomes (1)

  • Exercise duration

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

    through study completion, an average of a year

Secondary Outcomes (4)

  • Dyspnea

    through study completion, an average of a year

  • cerebral oxygenated hemoglobin

    through study completion, an average of a year

  • Cardiac output

    through study completion an average of a year

  • Fatigue

    through study completion, an average of a year

Study Arms (2)

PAH patients

ACTIVE COMPARATOR

Supplementation of oxygen therapy (40% FiO2) during steady state cardiopulmonary exercise testing, via Venturi mask

Drug: Oxygen supplementation

PAH patients (crossover)

SHAM COMPARATOR

Supplementation of medical air (sham oxygen) during steady state cardiopulmonary exercise testing, via Venturi mask

Drug: Sham O2 (medical air)

Interventions

Oxygen supplementationDRUG

40% FiO2 via Venturi mask

PAH patients
Sham O2 (medical air)DRUG

Medical air supplementation via Venturi mask

PAH patients (crossover)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Major contraindications for CPET conduction
  • Not providing informed consent -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

"G. Papanikolaou" General Hospital

Thessaloniki, 57010, Greece

RECRUITING

Related Publications (2)

  • 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.

    PMID: 34274251DERIVED

  • 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.

    PMID: 33957299DERIVED

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

Air

Condition Hierarchy (Ancestors)

Hypertension, PulmonaryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AtmosphereEnvironmentEcological and Environmental PhenomenaBiological PhenomenaMeteorological ConceptsEnvironment and Public Health

Study Officials

  • Georgia Pitsiou, MD, Ass Prof

    "G. Papanikolaou" General Hospital, Thessaloniki, Greece

    STUDY CHAIR

Central Study Contacts

Afroditi Boutou, MD, PhD, MSc

CONTACT

00306946611433afboutou@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant in Respiratory Medicine

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 25, 2018

Study Start

June 5, 2018

Primary Completion

June 10, 2019

Study Completion

June 30, 2019

Last Updated

September 25, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)