Supplemental Oxygen for Pulmonary Hypertension

(SOPHIE Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether extra oxygen during dialysis can benefit people with pulmonary hypertension, a condition where high blood pressure affects the lungs, and intradialytic hypoxemia, which means low oxygen levels during dialysis. The trial includes three groups: one will breathe regular room air, while the other two will receive different amounts of extra oxygen. It is ideal for those who regularly undergo dialysis, have been diagnosed with pulmonary hypertension, and experience low oxygen levels during treatment. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this new approach.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that many people with pulmonary hypertension use extra oxygen. Some studies found that patients with serious lung problems who used extra oxygen had a lower risk of dying, suggesting its potential benefits.

However, some people have reported practical issues with using oxygen, such as equipment problems or discomfort. No strong evidence indicates that oxygen therapy is harmful to those with pulmonary hypertension.

In this trial, participants will try different amounts of extra oxygen, receiving either a small or moderate amount. This treatment is generally safe for most people, but monitoring for any side effects remains important, as with any treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about supplemental oxygen treatment for pulmonary hypertension because it offers a simple, non-invasive approach to managing this condition. Unlike standard medications that often target specific pathways in the body, such as endothelin receptor antagonists or phosphodiesterase inhibitors, supplemental oxygen directly improves oxygen levels in the blood, which may help reduce stress on the heart and lungs. The trial is exploring different dosages, with 0.5 liters and 3 liters per minute, to determine the most effective amount, potentially offering a personalized treatment option. This approach could provide immediate benefits and be easily integrated into daily life, making it a promising alternative or addition to existing therapies.

What evidence suggests that this trial's treatments could be effective for pulmonary hypertension?

Research has shown that extra oxygen can help people with pulmonary hypertension. Studies have found that it eases exercise and breathing. In this trial, participants will be assigned to different arms to evaluate the effects of supplemental oxygen. Some will receive supplemental oxygen at 0.5 liters per minute, while others will receive it at 3 liters per minute. Patients who used extra oxygen in previous studies had a lower risk of death than those who didn't. Short-term oxygen use can improve heart and lung function, while long-term use helps patients walk farther. Overall, evidence supports oxygen therapy in managing symptoms and improving quality of life for these patients. ^{1 2 6 7 8}

Who Is on the Research Team?

Daniel Edmonston, MD, MHS

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11626617/

Supplementary oxygen efficacy for chronic pulmonary ... Our study revealed the efficacy of supplemental oxygen for EID and only a positive immediate effect on exercise capacity and dyspnoea.

2. jhltonline.org jhltonline.org/article/S1053-2498(18)31395-0/fulltext

Use of supplemental oxygen in patients with pulmonary ... Patients with severe DLCO reduction who used supplemental oxygen had a significantly lower risk of all-cause mortality than those who did not.

3. nature.com nature.com/articles/s41598-024-70650-w

Long-term oxygen therapy in precapillary pulmonary ... LTOT was well tolerated and led to significant improvement of 6MWD. The effect of LTOT should be investigated in larger controlled-trials.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1551713622001039

Oxygen Therapy in Pulmonary Vascular Disease There is convincing evidence that short-term supplemental oxygen therapy (SOT) improves pulmonary hemodynamics and prolongs exercise capacity. •. Long-term ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29653800/

Use of supplemental oxygen in patients with pulmonary ... Results: Of 3,046 patients, 57% used supplemental oxygen and 43% did not. Supplemental oxygen users had worse prognostic factors and more PAH-specific ...

6. academic.oup.com academic.oup.com/eurheartj/article/45/4/309/7469303

Overnight exposure to high altitude in pulmonary hypertension Pulmonary hypertension (PH) guidelines recommend that symptomatic PVD patients should not travel >1500 m or fly without supplemental oxygen therapy (SOT).

7. bmjopenrespres.bmj.com bmjopenrespres.bmj.com/content/12/1/e003086

Effects of pulmonary arterial hypertension therapies on ... Conclusion There is currently no consistent evidence from RCTs to suggest a deleterious effect of PAH therapies on arterial oxygenation in ...

8. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.201703-209OC

Annals of the American Thoracic Society This paper presents patient-reported data collected from supplemental oxygen users that identify the frequency and type of problems that they ...