Heart FailureNCT07874386
Wearable Tissue Oximetry During Arm Cuff Occlusion, Walking, and Standing Tests in Outpatients With Chronic Heart Failure
An observational study of Heart Failure and Chronic Heart Failure, run by NIRSense Inc. at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure, Chronic Heart Failure
- What is being tested?
- Argus Oximetry System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2023to 15 Mar 2026
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with previously diagnosed heart failure in New York Heart Association class I, II, or III, recruited from the existing patient population of an outpatient cardiology practice (Jackson Heart Clinic, Jackson, Mississippi) through clinic flyers, approach by clinic staff, and phone contact at scheduling.
Who may be able to join
- 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
Who cannot join
- Prior known severe allergy to medical-grade adhesive or tape (self-reported)
- Pregnant (self-reported)
- Diagnosed anemia (self-reported)
- History of sickle cell trait or thalassemia (self-reported)
- Diagnosed with Stage 4 heart failure according to the NYHA classification
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of NIRSense Total Oximetry Monitoring of Cardiopulmonary Function
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 two adhesive optical sensors on the forearm and sternum and completed two standard tests: a blood pressure cuff occlusion of the arm (vascular occlusion test) and a six-minute walk test. 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.
Read the detailed description
Background: Tissue oximeters use near-infrared spectroscopy (NIRS) to estimate tissue oxygenation noninvasively. NIRS tissue oximetry is used in surgery and intensive care, but low-burden wearable NIRS patches are recent, and their use in cardiovascular disease has not been assessed. Heart failure severity in outpatients is graded mainly by NYHA functional class, a clinical judgment. This pilot study examined whether tissue oxygenation measured by a wearable sensor during standardized tests relates to NYHA class.
Device: The NIRSense Argus Oximetry System (also called Envello Core) is an investigational, non-significant-risk, noninvasive wearable optical monitor. It consists of a reusable optical sensor with red and near-infrared light sources and detectors, a single-use medical-grade adhesive, and a display unit (tablet) that receives and stores the data. It measures relative tissue oxygenation by NIRS and, by photoplethysmography, pulse oximetry and pulse rate. The device has not been cleared or approved by the U.S. FDA. The study was conducted under the abbreviated investigational device exemption requirements for non-significant-risk devices.
Design: Single-center, prospective, observational study at an outpatient cardiology practice. Adults with heart failure in NYHA class I, II, or III were recruited from the clinic's patient population through flyers, staff approach, and phone contact at scheduling, and grouped by NYHA class. Each participant completed one visit. Two sensors were applied: on the dominant forearm over the wrist extensor muscles, and vertically on the sternum. Participants then completed three tests under clinical supervision. (1) Vascular occlusion test, performed twice: after a blood pressure measurement, a cuff on the upper arm was inflated to 50 mmHg above systolic pressure until forearm tissue oxygen saturation fell to 40% or for a maximum of 3 minutes, then released; the second test followed after tissue oxygenation had returned to baseline. (2) Six-minute walk test, with distance, breaks, and blood pressure before and after recorded. Pulse oximetry and pulse rate were recorded with a standard pulse oximeter. There was no follow-up visit.
Data collected: Continuous sensor data from the three sites during all tests; date of birth, sex, height, weight, NYHA class, Fitzpatrick skin type, and medical history; blood pressure, pulse rate, pulse oximetry, and six-minute walk distance; adverse events, protocol deviations, and device deficiencies on the case report form.
Analysis: Sensor data were separated by test. Deoxygenation and reoxygenation features were extracted for the vascular occlusion and 6MWT. Descriptive statistics were calculated for each NYHA class and each metric. Normality was assessed with Shapiro-Wilk tests. Correlations between sensor metrics and clinical measures were tested with Spearman tests, and NYHA classes were compared with Kruskal-Wallis analyses.
Enrollment: The protocol planned up to 200 participants. The sponsor closed enrollment after 50 participants, all of whom completed the visit. This record was registered after the study was completed.
- Conditions
- Heart Failure, Chronic Heart Failure
- Being tested
- Argus Oximetry System
- Keywords
- near-infrared spectroscopy, tissue oximetry, tissue oxygen saturation, wearable sensor, vascular occlusion test, reactive hyperemia, six-minute walk test, orthostatic, microvascular function, NYHA functional class
- Medical subject headings
- Heart Failure, Hyperemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argus Oximetry SystemDevice
Also called Envello Core, NIRSense Envello Core, NIRSense Sensor Patch, Argus Tissue Oximeter
Investigational wearable optical sensors using near-infrared spectroscopy and photoplethysmography to measure tissue oxygenation, pulse oximetry, and pulse rate. Three sensors are applied with a medical-grade adhesive to the dominant forearm and the sternum and worn during a single clinic visit while the participant completes a vascular occlusion test (twice) and a six-minute walk test. Sensor data are collected for research only and are not used for treatment decisions.
| Study group | Role | What they receive |
|---|---|---|
| NYHA class I | Adults with heart failure classified as New York Heart Association class I at enrollment. Receives: Device: Argus Oximetry System | |
| NYHA class II | Adults with heart failure classified as New York Heart Association class II at enrollment. Receives: Device: Argus Oximetry System | |
| NYHA class III | Adults with heart failure classified as New York Heart Association class III at enrollment. Receives: Device: Argus Oximetry System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm tissue oxygenation kinetics during and after vascular occlusion, by NYHA class
The primary VOT endpoint was post-occlusion net area under the curve (net AUC; a.u.×s), integrated from cuff release over 3 minutes.
Measured: 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 reoxygenation post six-minute walk test, by NYHA class
The primary 6MWT endpoint was post-walk recovery net AUC over the 3 minutes after walking
Measured: Day 1 (single study visit), during the six-minute walk test
Secondary outcomes (2)
Correlation between sensor tissue oxygenation metrics and standard clinical measures
Spearman correlation coefficients, within and across NYHA classes, between NIRSense tissue oxygenation metrics from each test and the standard measures recorded during the same test: blood pressure, pulse rate, and pulse oximetry for the vascular occlusion test; six-minute walk distance, blood pressure before and after the walk, pulse rate, and pulse oximetry for the walk test; supine-to-standing systolic blood pressure difference, pulse rate, and pulse oximetry for the postural test.
Measured: Day 1 (single study visit), during the vascular occlusion, six-minute walk, and postural tests
Number of participants with adverse events and number of device deficiencies
Adverse events (including skin irritation at the adhesive site and events during the walk test such as dizziness or falls) and device deficiencies recorded on the case report form.
Measured: Day 1, from sensor application through the end of the study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start14 Nov 2023
- Primary completion7 Aug 2025
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NIRSense Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Douglas D. Harkins, MD, Principal investigator, Jackson Heart ClinicThibault Roumengous, PhD, Study director, NIRSense Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874386
- Sponsor's protocol ID
- NSE2309
- Other IDs
- 20233808
- Status last verified
- Nov 2026
- First submitted
- 8 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be shared. Study data are the confidential property of the sponsor under the Clinical Trial Agreement between NIRSense, Inc. and Jackson Heart Clinic.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of NIRSense Total Oximetry Monitoring of Cardiopulmonary Function
- ClinicalTrials.gov ID
- NCT07874386
- Acronym / sponsor ID
- NSE2309
- Conditions
- Heart Failure, Chronic Heart Failure
- Keywords
- near-infrared spectroscopy, tissue oximetry, tissue oxygen saturation, wearable sensor, vascular occlusion test, reactive hyperemia, six-minute walk test, orthostatic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NIRSense Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2023 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 14 Oct 2026 (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.
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 two adhesive optical sensors on the forearm and sternum and completed two standard tests: a blood pressure cuff occlusion of the arm (vascular occlusion test) and a six-minute walk test. 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.
Detailed description
Background: Tissue oximeters use near-infrared spectroscopy (NIRS) to estimate tissue oxygenation noninvasively. NIRS tissue oximetry is used in surgery and intensive care, but low-burden wearable NIRS patches are recent, and their use in cardiovascular disease has not been assessed. Heart failure severity in outpatients is graded mainly by NYHA functional class, a clinical judgment. This pilot study examined whether tissue oxygenation measured by a wearable sensor during standardized tests relates to NYHA class.
Device: The NIRSense Argus Oximetry System (also called Envello Core) is an investigational, non-significant-risk, noninvasive wearable optical monitor. It consists of a reusable optical sensor with red and near-infrared light sources and detectors, a single-use medical-grade adhesive, and a display unit (tablet) that receives and stores the data. It measures relative tissue oxygenation by NIRS and, by photoplethysmography, pulse oximetry and pulse rate. The device has not been cleared or approved by the U.S. FDA. The study was conducted under the abbreviated investigational device exemption requirements for non-significant-risk devices.
Design: Single-center, prospective, observational study at an outpatient cardiology practice. Adults with heart failure in NYHA class I, II, or III were recruited from the clinic's patient population through flyers, staff approach, and phone contact at scheduling, and grouped by NYHA class. Each participant completed one visit. Two sensors were applied: on the dominant forearm over the wrist extensor muscles, and vertically on the sternum. Participants then completed three tests under clinical supervision. (1) Vascular occlusion test, performed twice: after a blood pressure measurement, a cuff on the upper arm was inflated to 50 mmHg above systolic pressure until forearm tissue oxygen saturation fell to 40% or for a maximum of 3 minutes, then released; the second test followed after tissue oxygenation had returned to baseline. (2) Six-minute walk test, with distance, breaks, and blood pressure before and after recorded. Pulse oximetry and pulse rate were recorded with a standard pulse oximeter. There was no follow-up visit.
Data collected: Continuous sensor data from the three sites during all tests; date of birth, sex, height, weight, NYHA class, Fitzpatrick skin type, and medical history; blood pressure, pulse rate, pulse oximetry, and six-minute walk distance; adverse events, protocol deviations, and device deficiencies on the case report form.
Analysis: Sensor data were separated by test. Deoxygenation and reoxygenation features were extracted for the vascular occlusion and 6MWT. Descriptive statistics were calculated for each NYHA class and each metric. Normality was assessed with Shapiro-Wilk tests. Correlations between sensor metrics and clinical measures were tested with Spearman tests, and NYHA classes were compared with Kruskal-Wallis analyses.
Enrollment: The protocol planned up to 200 participants. The sponsor closed enrollment after 50 participants, all of whom completed the visit. This record was registered after the study was completed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NYHA class I | – | Device: Argus Oximetry SystemAdults with heart failure classified as New York Heart Association class I at enrollment. |
| NYHA class II | – | Device: Argus Oximetry SystemAdults with heart failure classified as New York Heart Association class II at enrollment. |
| NYHA class III | – | Device: Argus Oximetry SystemAdults with heart failure classified as New York Heart Association class III at enrollment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with previously diagnosed heart failure in New York Heart Association class I, II, or III, recruited from the existing patient population of an outpatient cardiology practice (Jackson Heart Clinic, Jackson, Mississippi) through clinic flyers, approach by clinic staff, and phone contact at scheduling.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Prior known severe allergy to medical-grade adhesive or tape (self-reported)
- Pregnant (self-reported)
- Diagnosed anemia (self-reported)
- History of sickle cell trait or thalassemia (self-reported)
- Diagnosed with Stage 4 heart failure according to the NYHA classification
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 |
|---|---|---|
| Argus Oximetry SystemAlso: Envello Core, NIRSense Envello Core, NIRSense Sensor Patch, Argus Tissue OximeterInvestigational wearable optical sensors using near-infrared spectroscopy and photoplethysmography to measure tissue oxygenation, pulse oximetry, and pulse rate. Three sensors are applied with a medical-grade adhesive to the dominant forearm and the sternum and worn during a single clinic visit while the participant completes a vascular occlusion test (twice) and a six-minute walk test. Sensor data are collected for research only and are not used for treatment decisions. | Device | NYHA class I, NYHA class II, NYHA class III |
Primary outcome
Forearm tissue oxygenation kinetics during and after vascular occlusion, by NYHA class
Time frame: 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
The primary VOT endpoint was post-occlusion net area under the curve (net AUC; a.u.×s), integrated from cuff release over 3 minutes.
Rate and magnitude of tissue reoxygenation post six-minute walk test, by NYHA class
Time frame: Day 1 (single study visit), during the six-minute walk test
The primary 6MWT endpoint was post-walk recovery net AUC over the 3 minutes after walking
2 secondary outcomes
Correlation between sensor tissue oxygenation metrics and standard clinical measures
Time frame: Day 1 (single study visit), during the vascular occlusion, six-minute walk, and postural tests
Number of participants with adverse events and number of device deficiencies
Time frame: Day 1, from sensor application through the end of the study visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Companion reference-oximetry validation study of the same sensor systemLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Study data are the confidential property of the sponsor under the Clinical Trial Agreement between NIRSense, Inc. and Jackson Heart Clinic.
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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.
Douglas D. Harkins, MD principal investigator
Jackson Heart Clinic
Thibault Roumengous, PhD study director
NIRSense Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Chronic Heart Failure, run by NIRSense Inc. at 1 site 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Forearm tissue oxygenation kinetics during and after vascular occlusion, by NYHA class (time frame: 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). The study lists 2 primary outcomes in all. 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 6 Nov 2026.