CardiotoxicityNOECHONCT07158450
Novel On-body Evaluation of Cardiac Health for Oncology
An observational study of Cardiotoxicity and Heart Failure, run by Skribe Medical at 11 sites in United States.
Trial summary
The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiotoxicity, Heart Failure
- How many people
- 1,000 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 Oct 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (≥18 years) recruited from participating cardiology clinics. Participants are assigned to one of three cohorts by transthoracic echocardiography (TTE): Healthy (no known structural heart disease; LVEF ≥ 55%), Borderline/Possibly reduced LVEF (LVEF 40-54% or clinical concern for decline), and Reduced LVEF (LVEF < 40%). The population is intended to span the full spectrum of systolic function for model training and evaluation.
Who may be able to join
- Undergoing an echocardiogram irrespective of participation in this study
- Willing and able to provide informed consent prior to any study-related activity
Who cannot join
- Have a documented allergy to potential tissue contacting system materials
- Have any condition that would cause inaccurate TTE measurements
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites
Capital Cardiology Associates
Albany, New York, 12211
Clearwater Cardiovascular Consultants
Clearwater, Florida, 33756
Stern Cardiovascular Center
Germantown, Tennessee, 38138
Colorado Heart and Vascular
Golden, Colorado, 80401
Cardiovascular Institute of the South
Houma, Louisiana, 70360
First Coast Cardiovascular Institute
Jacksonville, Florida, 32256
South Denver Cardiology
Littleton, Colorado, 80120
Midwest Cardiovascular Institute
Naperville, Illinois, 60540
Virginia Commonwealth University
Richmond, Virginia, 23219
Strong Memorial Hospital
Rochester, New York, 14642
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, 19067
About this study
Official title: Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study
The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.
- Conditions
- Cardiotoxicity, Heart Failure
- Medical subject headings
- Cardiotoxicity, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy | No known or suspected cardiac disease | |
| Borderline LVEF | Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction | |
| Reduced LVEF | Known diagnosis of reduced left ventricular ejection fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates
The primary analysis will compute the correlation coefficient (r) between wearable-derived model estimates of LVEF and transthoracic echocardiography-derived LVEF in the Hold-Out Test Set. The prespecified performance target is r > 0.70.
Measured: From baseline through study completion (up to 6 months) at each paired assessment
Secondary outcomes (1)
Clinical accuracy of wearable-derived LVEF compared with echocardiography
Proportion of predictions within ±5 percentage points of TTE-derived LVEF in the Hold-Out Test Set. Error metrics will be calculated as Mean Absolute Error (MAE) between wearable-derived and TTE-derived LVEF. Differences across subgroups will be tested with ANOVA or Kruskal-Wallis as appropriate. Prespecified performance target: MAE ≤ 5 percentage points.
Measured: From baseline through study completion (up to 6 months) at each paired assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start9 Oct 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skribe Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158450
- Sponsor's protocol ID
- SKR-LVEF-001
- Acronym
- NOECHO
- Status last verified
- Oct 2026
- First submitted
- 28 Aug 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Individual participant data will not be shared due to proprietary device algorithms and consent restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Wearable Sensor-Based Estimation of Left Ventricular Ejection Fraction (LVEF) - Pilot Study
- ClinicalTrials.gov ID
- NCT07158450
- Acronym / sponsor ID
- NOECHO / SKR-LVEF-001
- Conditions
- Cardiotoxicity, Heart Failure
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Skribe MedicalIndustry (pharma, biotech, devices)
- Collaborators
- University of Rochester
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Sep 2025 (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.
The goal of this study is to develop a wearable sensor system that can estimate left ventricular ejection fraction (LVEF), which is a measurement of the heart's function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Healthy | – | –No known or suspected cardiac disease |
| Borderline LVEF | – | –Known conditions that may predispose to LV dysfunction, but no prior diagnosis of reduced left ventricular ejection fraction |
| Reduced LVEF | – | –Known diagnosis of reduced left ventricular ejection fraction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (≥18 years) recruited from participating cardiology clinics. Participants are assigned to one of three cohorts by transthoracic echocardiography (TTE): Healthy (no known structural heart disease; LVEF ≥ 55%), Borderline/Possibly reduced LVEF (LVEF 40-54% or clinical concern for decline), and Reduced LVEF (LVEF < 40%). The population is intended to span the full spectrum of systolic function for model training and evaluation.
Key inclusion criteria (2 listed)
- Undergoing an echocardiogram irrespective of participation in this study
- Willing and able to provide informed consent prior to any study-related activity
Key exclusion criteria (2 listed)
- Have a documented allergy to potential tissue contacting system materials
- Have any condition that would cause inaccurate TTE measurements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates
Time frame: From baseline through study completion (up to 6 months) at each paired assessment
The primary analysis will compute the correlation coefficient (r) between wearable-derived model estimates of LVEF and transthoracic echocardiography-derived LVEF in the Hold-Out Test Set. The prespecified performance target is r > 0.70.
1 secondary outcome
Clinical accuracy of wearable-derived LVEF compared with echocardiography
Time frame: From baseline through study completion (up to 6 months) at each paired assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to proprietary device algorithms and consent restrictions.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiotoxicity and Heart Failure, run by Skribe Medical at 11 sites 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 2 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation between wearable-derived and transthoracic echocardiography-derived left ventricular ejection fraction estimates (time frame: From baseline through study completion (up to 6 months) at each paired assessment). 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 5 Oct 2026.