A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia
SOPHIE
1 other identifier
interventional
10
1 country
11
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2026
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2024
CompletedFirst Posted
Study publicly available on registry
March 25, 2024
CompletedStudy Start
First participant enrolled
July 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
Study Completion
Last participant's last visit for all outcomes
June 30, 2027
August 27, 2025
August 1, 2025
12 months
March 18, 2024
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change daily hypoxemia burden
Minutes with oxygen saturation \<90% over a 24-hour period assessed by pulse oximetry
Weeks 1, 2, and 3
Secondary Outcomes (2)
Change in six minute walk distance
Weeks 1 and 3
Change in Montreal Cognitive Assessment (MoCA)
Weeks 1 and 3
Study Arms (3)
Room air
PLACEBO COMPARATORParticipants will receive no supplemental oxygen.
Supplemental oxygen (0.5 liters per minute)
EXPERIMENTALParticipants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 0.5 liters per minute.
Supplemental oxygen (3 liters per minute)
EXPERIMENTALParticipants will receive supplemental oxygen by oxygen concentrator delivered by nasal cannula at 3 liters per minute.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- Daily supplemental oxygen use
- Inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
Study Sites (11)
Davita Durham East
Durham, North Carolina, 27701, United States
Davita Durham Downtown
Durham, North Carolina, 27703, United States
Davita Research Triangle Park
Durham, North Carolina, 27703, United States
Davita Durham Regional
Durham, North Carolina, 27704, United States
Davita Durham West
Durham, North Carolina, 27705, United States
Davita Bull City
Durham, North Carolina, 27707, United States
Davita Durham Southpoint
Durham, North Carolina, 27713, United States
Davita Hope Valley
Durham, North Carolina, 27713, United States
Davita Vance County
Henderson, North Carolina, 27536, United States
Davita Kerr Lake
Henderson, North Carolina, 27537, United States
Davita Roxboro
Roxboro, North Carolina, 27573, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Edmonston, MD, MHS
Duke University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2024
First Posted
March 25, 2024
Study Start (Estimated)
July 1, 2026
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
August 27, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share