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Life sciences · Observational Study
ClinicalTrials.gov · October 14, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07874386). This is a study registration, not published results. Lead sponsor: NIRSense Inc.. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 50 participants (ACTUAL). Conditions: Heart Failure, Chronic Heart Failure. Interventions: DEVICE: Argus Oximetry System. Primary outcome measures: Forearm tissue oxygenation kinetics during and after vascular occlusion, by NYHA class , Day 1 (single study visit), from cuff inflation (up to 3 minutes of occlusion) through return to baseline after cuff release, for each of two tests; Rate and magnitude of tissue oxygenation decrease during a six-minute walk test, by NYHA class , Day 1 (single study visit), during the six-minute walk test; Rate and magnitude of tissue oxygenation decrease on standing from a supine position, by NYHA class , Day 1 (single study visit), from 3 minutes before standing through the third blood pressure reading after standing. Brief summary: This prospective, single-center, observational pilot study evaluated an investigational wearable tissue oximeter (NIRSense Argus Oximetry System, also called Envello Core) in adult outpatients with chronic heart failure in New York Heart Association (NYHA) class I, II, or III at Jackson Heart Clinic in Jackson, Mississippi. During one routine clinic visit, participants wore three adhesive optical sensors, on the forearm, the thigh, and the sternum, while completing three standard tests: a blood pressure cuff occlusion of the arm (vascular occlusion test), a six-minute walk test, and a change from lying down to standing. The sensors use near-infrared spectroscopy to record changes in tissue oxygenation. The study compared tissue oxygenation responses across NYHA classes and with standard clinical measures (blood pressure, pulse rate, pulse oximetry, and walk distance). Participation added about 30 minutes to the visit, with no follow-up. Fifty participants were enrolled. No treatment decisions were based on the study device.