Oxygen Treatment and Pulmonary Arterial Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-05

Study Completion Date

2019-06-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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PAH patients

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

Group Type ACTIVE_COMPARATOR

Oxygen supplementation

Intervention Type DRUG

40% FiO2 via Venturi mask

PAH patients (crossover)

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

Group Type SHAM_COMPARATOR

Sham O2 (medical air)

Intervention Type DRUG

Medical air supplementation via Venturi mask

Interventions

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Oxygen supplementation

40% FiO2 via Venturi mask

Intervention Type DRUG

Sham O2 (medical air)

Medical air supplementation via Venturi mask

Intervention Type DRUG

Eligibility Criteria

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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