Clinical trial NCT03993886: A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
Official title: A Study AnalyZing a NovEl Wearable SeNsor for Remote PatIent Health Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Chronic Kidney Diseases
Keywords: Hemodialysis
Lead sponsor: ReThink Medical
Sponsor class: INDUSTRY
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2019-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Multi-Arm study with different patient populations evaluating the CorBand.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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.

Eligibility criteria: INCLUSION:

Arm 1:

1. Subject is ≥ 18 years of age (legal age to give informed consent).
2. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
3. 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:

1. Subject is ≥ 18 years of age (legal age to give informed consent).
2. Subject receives chronic hemodialysis.
3. Subject undergoes at least two hemodialysis sessions per week.
4. 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:

1. Subject is ≥ 18 years of age (legal age to give informed consent).
2. Subject is implanted with the CardioMEMS HF device.
3. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
4. 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:

1. Subject is ≥ 18 years of age (legal age to give informed consent).
2. Subject is NYHA class I, II, III, or IV or undergoing cardiac management at the time of enrollment.
3. 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.
4. 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.

EXCLUSION:

1. The subject is unable or refuses to sign the informed consent.
2. Subject is pregnant or planning to become pregnant during the study.
3. A life expectancy of less than 6 months per clinician discretion.
4. Subject has an implanted pacemaker or pacing device (Arm 1 and Arm 2 only).
5. Poor healthcare literacy that would prevent the subjects from using the CorBand and/or completing questionnaires.
6. Physical or mental impairment preventing use of the CorBand or compliance with study requirements.
7. Material sensitivity to wearable devices, including the CorBand device.

   Additional Exclusion Criteria for Arm 4 Only:
8. Home use of intravenous continuous inotropes or planned outpatient weekly inotrope infusions.
9. Subject has been implanted with a ventricular assist device.
10. Subject is listed on heart transplant list.
11. Subject has a glomerular filtration rate (GFR) less than 30 mL/min.
12. 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.
13. Subject is undergoing or expected to undergo chronic hemodialysis (regularly scheduled sessions unrelated to a worsening heart failure event) during the study.
14. Subject is incompatible with CorBand (e.g., skin type resulting in poor data measurements).

Primary outcomes:
measure: Study Endpoint: Heart Rate
timeFrame: Through study completion, an average of 1 week
measure: Study Endpoint: Heart Rate Variability
timeFrame: Through study completion, an average of 1 week
measure: Study Endpoint: Respiration Rate
timeFrame: Through study completion, an average of 1 week
measure: Study Endpoint: Activity
timeFrame: Through study completion, an average of 1 week
measure: Study Endpoint: Skin Temperature
timeFrame: Through study completion, an average of 1 week
measure: Study Endpoint: Bioimpedance (Extracellular fluid differences)
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
Other outcomes:
measure: Incidence of investigational device related adverse events
timeFrame: Through study completion, an average of 1 week
measure: Patient Experience
timeFrame: Through study completion, an average of 1 week
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: San Jose
country: United States
facility: Satellite Healthcare
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jamie Kennedy, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: WRITING 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.
citation: Chaudhry 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.