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Oxygen Treatment and Pulmonary Arterial Hypertension

NCT03683082 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-09-25

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Oxygen supplementation

40% FiO2 via Venturi mask

DRUG

Sham O2 (medical air)

Medical air supplementation via Venturi mask

Sponsors & Collaborators

  • George Papanicolaou Hospital

    lead OTHER

Principal Investigators

  • Georgia Pitsiou, MD, Ass Prof · "G. Papanikolaou" General Hospital, Thessaloniki, Greece

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-06-10
Completion
2019-06-30

Countries

  • Greece

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683082 on ClinicalTrials.gov