Heart FailureZENITHNCT03993886
A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
A study testing CorBand, Activity Monitor and Bioimpedance spectrometer in people with Heart Failure and Chronic Kidney Diseases, run by ReThink Medical at 2 sites in United States.
Trial summary
Evaluate the performance of the CorBand product when used to monitor patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Chronic Kidney Diseases
- What is being tested?
- CorBand, Activity Monitor and Bioimpedance spectrometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2019to 14 Jul 2020
- Phase
- Interventional
- 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
Who may be able to join
- Arm 1:
- Subject is ≥ 18 years of age (legal age to give informed consent).
- Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
- Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
- Arm 2:
- Subject is ≥ 18 years of age (legal age to give informed consent).
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- Subject receives chronic hemodialysis.
- Subject undergoes at least two hemodialysis sessions per week.
- Willing and capable of participating in all study visits and comply with medication/treatment requirements associated with this clinical study at an approved clinical study center.
- Arm 3:
- Subject is ≥ 18 years of age (legal age to give informed consent).
- Subject is implanted with the CardioMEMS HF device.
- Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
- Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
- Arm 4:
- Subject is ≥ 18 years of age (legal age to give informed consent).
- Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
- Subject is stabilized during (and not yet discharged from) a hospitalization for exacerbation of symptomatic heart failure or a clinic visit for symptomatic heart failure associated with unscheduled treatment with IV diuretics.
- Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
Who cannot join
- The subject is unable or refuses to sign the informed consent.
- Subject is pregnant or planning to become pregnant during the study.
- A life expectancy of less than 6 months per clinician discretion.
- Subject has an implanted pacemaker or pacing device (Arm 1 and Arm 2 only).
- Poor healthcare literacy that would prevent the subjects from using the CorBand and/or completing questionnaires.
- Physical or mental impairment preventing use of the CorBand or compliance with study requirements.
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- Material sensitivity to wearable devices, including the CorBand device.
- Additional Exclusion Criteria for Arm 4 Only:
- Home use of intravenous continuous inotropes or planned outpatient weekly inotrope infusions.
- Subject has been implanted with a ventricular assist device.
- Subject is listed on heart transplant list.
- Subject has a glomerular filtration rate (GFR) less than 30 mL/min.
- Subject has uncontrolled hypertension defined as 160/100 mmHg on two consecutive readings taken 15 min apart after subject has been resting for 15 min.
- Subject is undergoing or expected to undergo chronic hemodialysis (regularly scheduled sessions unrelated to a worsening heart failure event) during the study.
- Subject is incompatible with CorBand (e.g., skin type resulting in poor data measurements).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Francisco
San Francisco, California, 94143
Satellite Healthcare
San Jose, California, 95128
About this study
Evaluate the performance of the CorBand product when used to monitor patients.
Read the detailed description
The goal of the study is to demonstrate the validity and reliability of the CorBand across a suite of six clinical measures by comparing the measurements to similar outputs of FDA cleared devices:
- CorBand heart rate and heart rate variability will be compared to an electrocardiogram.
- CorBand bioimpedance will be compared to recorded extracted fluid and a bioimpedance measurement device.
- CorBand respiration rate will be compared to an respiratory rate sensor.
- CorBand skin temperature will be compared to a skin temperature monitoring device.
- CorBand activity will be compared to an activity monitor.
- CorBand outputs will be compared to the outputs of the CardioMEMS system.
Device safety, comfort, and ease-of-use will also be evaluated as part of this study. Adverse events and serious adverse events will be documented throughout the study duration.
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Being tested
- CorBand, Activity Monitor, Bioimpedance spectrometer, ECG, respiratory rate sensor
- Keywords
- Hemodialysis
- Medical subject headings
- Heart Failure, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CorBandDevice
The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.
Activity MonitorOther
commercially available accelerometer to be worn on wrist
Bioimpedance spectrometerOther
Commercially available bioimpedance monitor.
ECGOther
Commercially available electrocardiogram machine
respiratory rate sensorOther
Commercially available respiratory rate sensor.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Adult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management. Receives: Device: CorBand; Other: ECG; Other: respiratory rate sensor |
| Arm 2 | Other | Adult (≥ 18 years of age) patients undergoing chronic hemodialysis. Receives: Device: CorBand; Other: Activity Monitor; Other: Bioimpedance spectrometer |
| Arm 3 | Other | Adult (≥ 18 years of age) patients (i) implanted with the CardioMEMS HF device and (ii) diagnosed with heart failure and/or undergoing cardiac management. Receives: Device: CorBand |
| Arm 4 | Other | Adult (≥ 18 years of age) patients diagnosed with heart failure and/or undergoing cardiac management. Receives: Device: CorBand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Endpoint: Heart Rate
To evaluate the accuracy of the heart rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Measured: Through study completion, an average of 1 week
Study Endpoint: Heart Rate Variability
To evaluate the accuracy of the heart rate variability data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Measured: Through study completion, an average of 1 week
Study Endpoint: Respiration Rate
To evaluate the accuracy of the respiration rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Measured: Through study completion, an average of 1 week
Study Endpoint: Activity
To evaluate the accuracy of the activity (steps/movement) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Measured: Through study completion, an average of 1 week
Study Endpoint: Skin Temperature
To evaluate the accuracy of the skin temperature data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Measured: Through study completion, an average of 1 week
Study Endpoint: Bioimpedance (Extracellular fluid differences)
To evaluate the accuracy of the bioimpedance (extracellular fluid differences) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Measured: Through study completion, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2019
- Study start17 Jan 2019
- Primary completion30 Jun 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Multi-Arm study with different patient populations evaluating the CorBand.
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- ReThink Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Jamie Kennedy, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993886
- Sponsor's protocol ID
- P 005
- Other IDs
- 5R44HL125001-03
- Acronym
- ZENITH
- Status last verified
- Jul 2020
- First submitted
- 24 Apr 2019
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
PubMed 26811276WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.
PubMed 23741058Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
PubMed 21080835
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
- ClinicalTrials.gov ID
- NCT03993886
- Acronym / sponsor ID
- ZENITH / P 005
- Conditions
- Heart Failure, Chronic Kidney Diseases
- Keywords
- Hemodialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ReThink MedicalIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 21 Jun 2019 (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.
Evaluate the performance of the CorBand product when used to monitor patients.
Detailed description
The goal of the study is to demonstrate the validity and reliability of the CorBand across a suite of six clinical measures by comparing the measurements to similar outputs of FDA cleared devices:
- CorBand heart rate and heart rate variability will be compared to an electrocardiogram.
- CorBand bioimpedance will be compared to recorded extracted fluid and a bioimpedance measurement device.
- CorBand respiration rate will be compared to an respiratory rate sensor.
- CorBand skin temperature will be compared to a skin temperature monitoring device.
- CorBand activity will be compared to an activity monitor.
- CorBand outputs will be compared to the outputs of the CardioMEMS system.
Device safety, comfort, and ease-of-use will also be evaluated as part of this study. Adverse events and serious adverse events will be documented throughout the study duration.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Multi-Arm study with different patient populations evaluating the CorBand.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Device: CorBand, Other: ECG, Other: respiratory rate sensorAdult (≥ 18 years of age) ambulatory patients diagnosed with heart failure and/or undergoing cardiac management. |
| Arm 2 | Other | Device: CorBand, Other: Activity Monitor, Other: Bioimpedance spectrometerAdult (≥ 18 years of age) patients undergoing chronic hemodialysis. |
| Arm 3 | Other | Device: CorBandAdult (≥ 18 years of age) patients (i) implanted with the CardioMEMS HF device and (ii) diagnosed with heart failure and/or undergoing cardiac management. |
| Arm 4 | Other | Device: CorBandAdult (≥ 18 years of age) patients diagnosed with heart failure and/or undergoing cardiac management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject is ≥ 18 years of age (legal age to give informed consent).
- Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
- Willing and capable of participating in all study visits and complying with medication/treatment requirements associated with this clinical study at an approved clinical study center.
- Subject is ≥ 18 years of age (legal age to give informed consent).
- Subject receives chronic hemodialysis.
Key exclusion criteria (15 listed)
- The subject is unable or refuses to sign the informed consent.
- Subject is pregnant or planning to become pregnant during the study.
- A life expectancy of less than 6 months per clinician discretion.
- Subject has an implanted pacemaker or pacing device (Arm 1 and Arm 2 only).
- Poor healthcare literacy that would prevent the subjects from using the CorBand and/or completing questionnaires.
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 |
|---|---|---|
| CorBandThe CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity. | Device | Arm 1, Arm 2, Arm 3, Arm 4 |
| Activity Monitorcommercially available accelerometer to be worn on wrist | Other | Arm 2 |
| Bioimpedance spectrometerCommercially available bioimpedance monitor. | Other | Arm 2 |
| ECGCommercially available electrocardiogram machine | Other | Arm 1 |
| respiratory rate sensorCommercially available respiratory rate sensor. | Other | Arm 1 |
Primary outcome
Study Endpoint: Heart Rate
Time frame: Through study completion, an average of 1 week
To evaluate the accuracy of the heart rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Heart Rate Variability
Time frame: Through study completion, an average of 1 week
To evaluate the accuracy of the heart rate variability data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Respiration Rate
Time frame: Through study completion, an average of 1 week
To evaluate the accuracy of the respiration rate data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Activity
Time frame: Through study completion, an average of 1 week
To evaluate the accuracy of the activity (steps/movement) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Skin Temperature
Time frame: Through study completion, an average of 1 week
To evaluate the accuracy of the skin temperature data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
Study Endpoint: Bioimpedance (Extracellular fluid differences)
Time frame: Through study completion, an average of 1 week
To evaluate the accuracy of the bioimpedance (extracellular fluid differences) data collected by the CorBand compared to gold standard monitor. (No therapy or health outcomes will be evaluated. Data will assist in developing the decision model using the feature selection for the CorBand algorithm.)
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 17 Jul 2020.
- Background: PubMed 26811276Writing Group Members; Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Despres JP, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jimenez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER 3rd, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; American Heart Association Statistics Committee; Stroke Statistics Subcommittee. Executive Summary: Heart Disease and Stroke Statistics--2016 Update: A Report From the American Heart Association. Circulation. 2016 Jan 26;133(4):447-54. doi: 10.1161/CIR.0000000000000366. No abstract available.
- Background: PubMed 23741058WRITING COMMITTEE MEMBERS; Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Drazner MH, Fonarow GC, Geraci SA, Horwich T, Januzzi JL, Johnson MR, Kasper EK, Levy WC, Masoudi FA, McBride PE, McMurray JJ, Mitchell JE, Peterson PN, Riegel B, Sam F, Stevenson LW, Tang WH, Tsai EJ, Wilkoff BL; American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013 Oct 15;128(16):e240-327. doi: 10.1161/CIR.0b013e31829e8776. Epub 2013 Jun 5. No abstract available.
- Background: PubMed 21080835Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.
- Individual participant dataSharing planned: No
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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.
Jamie Kennedy, MD principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CorBand, Activity Monitor and Bioimpedance spectrometer in people with Heart Failure and Chronic Kidney Diseases, run by ReThink Medical at 2 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 19 inclusion and 15 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 17 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Study Endpoint: Heart Rate (time frame: Through study completion, an average of 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03993886, which also lists 3 linked publications.
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 17 Jul 2020; AzTrials last refreshed its copy on 29 Oct 2026.