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NCT Number: NCT06327373

A Feasibility Study of Supplemental Oxygen to Improve Pulmonary Hypertension in People With Intradialytic Hypoxemia

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

Why the study stopped: Funding not obtained
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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Davita Bull City, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • Daily supplemental oxygen use
  • Inability to provide informed consent

Treatment and study plan

Oxygen

Drug

Supplemental oxygen by oxygen concentrator

Room Air

Drug

Room air without oxygen concentrator

Primary outcomes

  1. 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

Secondary outcomes

  1. Change in six minute walk distance

    Time frame: Weeks 1 and 3

    Scores are measured as meters walked during a six-minute assessment

  2. Change in Montreal Cognitive Assessment (MoCA)

    Time frame: Weeks 1 and 3

    Scores are measured on a 30-point scale

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: SOPHIE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2024
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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