Supplemental Oxygen for Pulmonary Hypertension

(SOPHIE Trial)

Recruiting at 10 trial locations

Overseen By Anastacia Bohannon

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Duke University

Disqualifiers: Daily oxygen use, inability to consent

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 3 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Oxygen, O2, for pulmonary hypertension?

Research shows that breathing oxygen-enriched air can improve exercise performance in patients with pulmonary hypertension, and oxygen acts as a pulmonary vasodilator (helps open blood vessels in the lungs), which may benefit patients even if they don't have low oxygen levels in their blood. ^{1 2 3 4 5}

Is supplemental oxygen safe for humans?

Supplemental oxygen is generally considered safe for humans, but it can have side effects if not used properly. It is important to follow medical guidelines, as too much oxygen can lead to hyperoxemia (excess oxygen in the blood), which can be harmful. ^{3 4 6 7 8}

How does the treatment of supplemental oxygen differ from other treatments for pulmonary hypertension?

Supplemental oxygen is unique because it acts as a pulmonary vasodilator (widens blood vessels in the lungs) and can benefit patients with pulmonary hypertension even if they are not experiencing low oxygen levels. Unlike other treatments, it can be administered at home, often at night, and its effectiveness is linked to the duration of daily use, typically recommended for at least 15 hours a day. ^{2 4 6 9 10}

Research Team

Daniel Edmonston, MD, MHS

Principal Investigator

Duke University

Eligibility Criteria

This trial is for individuals who have pulmonary hypertension (high blood pressure in the lungs) and experience low oxygen levels during hemodialysis, a treatment for kidney failure. Specific eligibility details are not provided.

Inclusion Criteria

I am on a hemodialysis schedule of either Monday-Wednesday-Friday or Tuesday-Thursday-Saturday.

I have pulmonary hypertension and experience significant drops in oxygen levels during dialysis.

Exclusion Criteria

I use supplemental oxygen every day.

Inability to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive supplemental oxygen or room air during hemodialysis

3 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Oxygen

Trial Overview The study is testing whether giving extra oxygen during hemodialysis can help people with lung-related high blood pressure compared to those breathing normal room air.

Participant Groups

Group I: Supplemental oxygen (3 liters per minute) Experimental Treatment 1 Intervention

Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.

Group II: Supplemental oxygen (0.5 liters per minute) Experimental Treatment 1 Intervention

Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.

Group III: Room air Placebo Group 1 Intervention

Participants will receive no supplemental oxygen.

Oxygen is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Oxygen for:

• General anesthesia
• Respiratory distress
• Cardiac arrest
• Hypoxia

Approved in European Union as Oxygen for:

• General anesthesia
• Respiratory distress
• Cardiac arrest
• Hypoxia

Approved in Canada as Oxygen for:

• General anesthesia
• Respiratory distress
• Cardiac arrest
• Hypoxia

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

In a study of 3,046 patients with pulmonary arterial hypertension (PAH), those with severe reduction in lung carbon monoxide diffusing capacity (DLCO) who used supplemental oxygen had a significantly lower risk of all-cause mortality (hazard ratio 0.56) compared to those who did not use oxygen.

There was no observed benefit of supplemental oxygen in patients with no, mild, or moderate DLCO reduction, indicating that oxygen therapy may be particularly beneficial for those with severe lung function impairment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of supplemental oxygen in patients with pulmonary arterial hypertension in REVEAL. Farber, HW., Badesch, DB., Benza, RL., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of domiciliary oxygen therapy on exercise capacity and quality of life in patients with pulmonary arterial or chronic thromboembolic pulmonary hypertension: a randomised, placebo-controlled trial. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Pulmonary hypertension with a low cardiac index requires a higher PaO2 level to avoid tissue hypoxia. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

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. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Oxygen and pulmonary arterial hypertension: effects, mechanisms, and therapeutic benefits. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Effect of breathing oxygen-enriched air on exercise performance in patients with precapillary pulmonary hypertension: randomized, sham-controlled cross-over trial. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Use of supplemental oxygen in patients with pulmonary arterial hypertension in REVEAL. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Controlled prospective randomised trial on the effects on pulmonary haemodynamics of the ambulatory long term use of nitric oxide and oxygen in patients with severe COPD. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

[German S3 Guideline - Oxygen Therapy in the Acute Care of Adult Patients]. [2022]

9. Italy pubmed.ncbi.nlm.nih.gov

Effects of oxygen therapy on pulmonary arterial hypertension in chronic obstructive lung disease. [2007]

10. United States pubmed.ncbi.nlm.nih.gov

Longterm favorable effect of oxygen administration on a patient with primary pulmonary hypertension. [2019]