Pulmonary HypertensionPhase 1/2SOPHIENCT06327373
A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
A Phase 1/2 study testing Oxygen and Room air in people with Pulmonary Hypertension, run by Duke University at 11 sites in United States.
Trial summary
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Oxygen and Room air
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years
- Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis
- Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity [TRV] >2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation <90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to <88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).
Who cannot join
- Daily supplemental oxygen use
- Inability to provide informed consent
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Davita Durham East
Durham, North Carolina, 27701
Davita Durham Downtown
Durham, North Carolina, 27703
Davita Research Triangle Park
Durham, North Carolina, 27703
Davita Durham Regional
Durham, North Carolina, 27704
Davita Durham West
Durham, North Carolina, 27705
Davita Bull City
Durham, North Carolina, 27707
Davita Durham Southpoint
Durham, North Carolina, 27713
Davita Hope Valley
Durham, North Carolina, 27713
Davita Vance County
Henderson, North Carolina, 27536
Davita Kerr Lake
Henderson, North Carolina, 27537
Davita Roxboro
Roxboro, North Carolina, 27573
About this study
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.
- Conditions
- Pulmonary Hypertension
- Being tested
- Oxygen, Room air
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
Supplemental oxygen by oxygen concentrator
Room airDrug
Room air without oxygen concentrator
| Study group | Role | What they receive |
|---|---|---|
| Room air | Placebo comparator | Participants will receive no supplemental oxygen. Receives: Drug: Room air |
| Supplemental oxygen (0.5 liters per minute) | Experimental | Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute. Receives: Drug: Oxygen |
| Supplemental oxygen (3 liters per minute) | Experimental | Participants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute. Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change daily hypoxemia burden
Minutes with oxygen saturation <90% over a 24-hour period assessed by pulse oximetry
Measured: Weeks 1, 2, and 3
Secondary outcomes (2)
Change in six minute walk distance
Scores are measured as meters walked during a six-minute assessment
Measured: Weeks 1 and 3
Change in Montreal Cognitive Assessment (MoCA)
Scores are measured on a 30-point scale
Measured: Weeks 1 and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: Funding not obtained
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Edmonston, MD, MHS, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327373
- Sponsor's protocol ID
- Pro00114903
- Acronym
- SOPHIE
- Status last verified
- Sep 2026
- First submitted
- 18 Mar 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
- ClinicalTrials.gov ID
- NCT06327373
- Acronym / sponsor ID
- SOPHIE / Pro00114903
- Conditions
- Pulmonary Hypertension
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding not obtained
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the feasibility of supplemental oxygen delivery during hemodialysis in people with pulmonary hypertension and intradialytic hypoxemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Room air | Placebo comparator | Drug: Room airParticipants will receive no supplemental oxygen. |
| Supplemental oxygen (0.5 liters per minute) | Experimental | Drug: OxygenParticipants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute. |
| Supplemental oxygen (3 liters per minute) | Experimental | Drug: OxygenParticipants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥18 years
- Receiving Monday-Wednesday-Friday or Tuesday-Thursday-Saturday hemodialysis
- Screened positive for pulmonary hypertension (defined by tricuspid regurgitant velocity [TRV] >2.5 m/s on echocardiography) and intradialytic hypoxemia (defined by spending ≥1/3 treatment with O2 saturation <90%) or hypoxemia for ≥10% of the treatment if associated with a desaturation event (≥4% decline in O2 saturation to <88% for ≥10 seconds) during enrollment in the PH-ESKD study (Pro00108710).
Key exclusion criteria (2 listed)
- Daily supplemental oxygen use
- Inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxygenSupplemental oxygen by oxygen concentrator | Drug | Supplemental oxygen (0.5 liters per minute), Supplemental oxygen (3 liters per minute) |
| Room airRoom air without oxygen concentrator | Drug | Room air |
Primary outcome
Change daily hypoxemia burden
Time frame: Weeks 1, 2, and 3
Minutes with oxygen saturation <90% over a 24-hour period assessed by pulse oximetry
2 secondary outcomes
Change in six minute walk distance
Time frame: Weeks 1 and 3
Change in Montreal Cognitive Assessment (MoCA)
Time frame: Weeks 1 and 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Edmonston, MD, MHS principal investigator
Duke University
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Oxygen and Room air in people with Pulmonary Hypertension, run by Duke University at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change daily hypoxemia burden (time frame: Weeks 1, 2, and 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.