Heart FailureNanosenseNCT03719079
Nanowear Heart Failure Management Multi-sensor Algorithm
An observational study of Heart Failure, run by Nanowear Inc. at 1 site in United States.
Trial summary
The NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which includes at least 150 heart failure hospitalizations in participating subjects.The duration… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- SimpleSENSE
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2019to 18 Jun 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects of legal age to give informed consent who are currently or recently hospitalized with a primary diagnosis of heart failure
Who may be able to join
- Subject has provided informed consent
- Male or female over the age of 18 years
- The patient is either hospitalized with a primary diagnosis of acute or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment
- NYHA functional class II-IV at time of enrollment
Who cannot join
- Subject unwilling or unable to comply with wearing the Nanowear Congestive Heart Failure Management System 12 hours daily for up to 90 days.
- Subjects who are limited by angina.
- Severe aortic stenosis.
- Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
- Symptomatic ventricular arrhythmias within the past 6 months.
- Subjects who are pregnant will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial
The NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which includes at least 150 heart failure hospitalizations in participating subjects.The duration of the NanoSense study is expected to be 2 years. The study device is the Wearable Congestive Heart Failure Management System (WCHFS, also known as SimpleSENSE)
Read the detailed description
NanoSense is a data collection study to develop a multi-sensor algorithm to predict worsening Heart Failure (HF). Subjects who meet the eligibility criteria and agree to participate in the study will enter the informed consent process in which the subject will be informed about the research study, the voluntary nature of the research and all attendant risks and benefits. Once the subject has been informed and all question answered, the subject will be asked to sign an informed consent document (approved by the local Institutional Review Board). At enrollment, data about subject demographics, cardiac disease history, and comorbidities will be collected. The subject vital signs, blood labs (as available; if an N-terminal pro b-type natriuretic peptide (NT-proBNP) is not available, one will be ordered to coincide with the next lab samples), HF medications and HF assessment measurements will be made and recorded. Subjects will be given a diary to record daily weights, diuretics changes, and weekly HF status. The subject will be fitted with a Nanowear Wearable Congestive Heart Failure System (WCHFS) and educated on the use of the system with attention to proper fit and changing or charging the battery daily depending on the type of battery used. Subjects who have a pacemaker or Implantable Cardioverter Defibrillator (ICD) will undergo pacemaker/ICD interrogation while wearing the device to assure that there are no electrical signals detected that may interfere with pacemaker or ICD function.
The subjects will be asked to wear the device for approximately 12 hours daily including 2 hours prior to sleep and 2 hours after awakening. The follow-up period will be 90 days. At visit 2, the clinical assessment will be repeated and recorded. The device will be retrieved from the subject. In the event that a subject is unable to travel to the investigator's site, the subject will be asked to mail the device back to the sponsor with use of a prepaid mailing package that will be delivered to the subject. Data may be obtained by phone if the subject is unable or unwilling to return for visit 2.
A final contact will be made to the subject at 30 days following visit 2 to determine whether there were any adverse effects that were not previously recognized that may be related to their participation in the study.
- Conditions
- Heart Failure
- Being tested
- SimpleSENSE
- Keywords
- Fluid decompensation, Non-invasive Multi-parameter monitoring, Multi-parameter algorithm, Heart Rate Variability, Thoracic impedance, Heart Sounds, Respiration, Posture, Activity, Tidal Volume, Stroke Volume
- Medical subject headings
- Heart Failure, Respiratory Aspiration, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimpleSENSEDevice
The Nanosense study is observational only. No interventions will be triggered by the SimpleSense device
| Study group | Role | What they receive |
|---|---|---|
| Heart Failure Patients | Patients with primary diagnosis as heart failure Receives: Device: SimpleSENSE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-parameter algorithm
The primary objective of the study is to develop and validate a multi-parameter algorithm for the detection of heart failure prior to a HF event. For the purpose of this study, a heart failure event will be defined as a hospitalization with a primary diagnosis of heart failure.
Measured: 90 days per patient and till 100 Heart Failure events are observed overall.
Secondary outcomes (1)
Exploratory comparison of signals from device to NT-proBNP
Exploratory information will be used to compare the signals obtained from the device to the severity of heart failure as measured by clinical evaluation (NYHA functional class and physical examination) and NT-proBNP
Measured: 90 days per patient and till 100 Heart Failure events are observed overall.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start21 Aug 2019
- Primary completion22 Mar 2021
- Study completion18 Jun 2024
Why it stopped: Logistics and low enrollment.
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
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanowear Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center, Hackensack Meridian Health
- Responsible party
- Sponsor
- Investigators
- John P Boehmer, M.D., Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03719079
- Sponsor's protocol ID
- NWCT18-SS-001
- Acronym
- Nanosense
- Status last verified
- Apr 2026
- First submitted
- 23 Oct 2018
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial
- ClinicalTrials.gov ID
- NCT03719079
- Acronym / sponsor ID
- Nanosense / NWCT18-SS-001
- Conditions
- Heart Failure
- Keywords
- Fluid decompensation, Non-invasive Multi-parameter monitoring, Multi-parameter algorithm, Heart Rate Variability, Thoracic impedance, Heart Sounds, Respiration, Posture
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Logistics and low enrollment.
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Nanowear Inc.Industry (pharma, biotech, devices)
- Collaborators
- Milton S. Hershey Medical Center, Hackensack Meridian Health
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 22 Mar 2021 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 25 Oct 2018 (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 NanoSense study is a multi-center, prospective, non-randomized, observational, feasibility, non-significant risk study. The NanoSense study will enroll up to 500 subjects in up to 10 centers in order to collect data which includes at least 150 heart failure hospitalizations in participating subjects.The duration of the NanoSense study is expected to be 2 years. The study device is the Wearable Congestive Heart Failure Management System (WCHFS, also known as SimpleSENSE)
Detailed description
NanoSense is a data collection study to develop a multi-sensor algorithm to predict worsening Heart Failure (HF). Subjects who meet the eligibility criteria and agree to participate in the study will enter the informed consent process in which the subject will be informed about the research study, the voluntary nature of the research and all attendant risks and benefits. Once the subject has been informed and all question answered, the subject will be asked to sign an informed consent document (approved by the local Institutional Review Board). At enrollment, data about subject demographics, cardiac disease history, and comorbidities will be collected. The subject vital signs, blood labs (as available; if an N-terminal pro b-type natriuretic peptide (NT-proBNP) is not available, one will be ordered to coincide with the next lab samples), HF medications and HF assessment measurements will be made and recorded. Subjects will be given a diary to record daily weights, diuretics changes, and weekly HF status. The subject will be fitted with a Nanowear Wearable Congestive Heart Failure System (WCHFS) and educated on the use of the system with attention to proper fit and changing or charging the battery daily depending on the type of battery used. Subjects who have a pacemaker or Implantable Cardioverter Defibrillator (ICD) will undergo pacemaker/ICD interrogation while wearing the device to assure that there are no electrical signals detected that may interfere with pacemaker or ICD function.
The subjects will be asked to wear the device for approximately 12 hours daily including 2 hours prior to sleep and 2 hours after awakening. The follow-up period will be 90 days. At visit 2, the clinical assessment will be repeated and recorded. The device will be retrieved from the subject. In the event that a subject is unable to travel to the investigator's site, the subject will be asked to mail the device back to the sponsor with use of a prepaid mailing package that will be delivered to the subject. Data may be obtained by phone if the subject is unable or unwilling to return for visit 2.
A final contact will be made to the subject at 30 days following visit 2 to determine whether there were any adverse effects that were not previously recognized that may be related to their participation in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart Failure Patients | – | Device: SimpleSENSEPatients with primary diagnosis as heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of legal age to give informed consent who are currently or recently hospitalized with a primary diagnosis of heart failure
Key inclusion criteria (4 listed)
- Subject has provided informed consent
- Male or female over the age of 18 years
- The patient is either hospitalized with a primary diagnosis of acute or was discharged with a primary diagnosis of acute heart failure within 2 weeks prior to enrollment
- NYHA functional class II-IV at time of enrollment
Key exclusion criteria (6 listed)
- Subject unwilling or unable to comply with wearing the Nanowear Congestive Heart Failure Management System 12 hours daily for up to 90 days.
- Subjects who are limited by angina.
- Severe aortic stenosis.
- Subjects who are hemodynamically unstable requiring support with intravenous vasoactive medications or mechanical circulatory support
- Symptomatic ventricular arrhythmias within the past 6 months.
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 |
|---|---|---|
| SimpleSENSEThe Nanosense study is observational only. No interventions will be triggered by the SimpleSense device | Device | Heart Failure Patients |
Primary outcome
Multi-parameter algorithm
Time frame: 90 days per patient and till 100 Heart Failure events are observed overall.
The primary objective of the study is to develop and validate a multi-parameter algorithm for the detection of heart failure prior to a HF event. For the purpose of this study, a heart failure event will be defined as a hospitalization with a primary diagnosis of heart failure.
1 secondary outcome
Exploratory comparison of signals from device to NT-proBNP
Time frame: 90 days per patient and till 100 Heart Failure events are observed overall.
Results and safety
The study was stopped early (reason given: Logistics and low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
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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.
John P Boehmer, M.D. principal investigator
Milton S. Hershey Medical Center
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, run by Nanowear 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 6 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: stopped early, as of the sponsor's last update on 9 Apr 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 was stopped early (reason given: Logistics and low enrollment.). Results are not available in the source record.
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?
Multi-parameter algorithm (time frame: 90 days per patient and till 100 Heart Failure events are observed overall.). 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 9 Apr 2026.