NCT07874386Completed
Wearable Tissue Oximetry During Arm Cuff Occlusion, Walking, and Standing Tests in Outpatients With Chronic Heart Failure
Clinical Evaluation of NIRSense Total Oximetry Monitoring of Cardiopulmonary Function
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 50 (actual)
- First submitted
- 8 Oct 2026
- Start date
- 14 Nov 2023
- Primary completion date
- 7 Aug 2025
- Lead sponsor
- NIRSense Inc.
- Diseases
- Heart failure
- NCT number
- NCT07874386
What you commit to
- Study type: Observational
- Participants enrolled: 50
- From 14 Nov 2023 to the primary completion date, 7 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior known severe allergy to medical-grade adhesive or tape (self-reported)
Other illness
- History of sickle cell trait or thalassemia (self-reported)
- Diagnosed with Stage 4 heart failure according to the NYHA classification
Other
- Pregnant (self-reported)
- Diagnosed anemia (self-reported)
Who the study is looking for
- Biological males and females between 18 and 85 years old
- Previously diagnosed with heart failure and currently considered a candidate for a diagnosis of Stage 1, Stage 2, or Stage 3 heart failure according to the New York Heart Association (NYHA) classification
- BMI between 18 and 40, with a minimum weight of 40 kg (upper BMI limit raised from 30 to 40 by an IRB-approved administrative change in October 2024)
- Currently able to ambulate independently to the required standards of the 6-minute walk test
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jackson Heart Clinic Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.