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Nanowear Heart Failure Management Multi-sensor Algorithm (Nanosense)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03719079
Recruitment Status : Recruiting
First Posted : October 25, 2018
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Milton S. Hershey Medical Center
Hackensack Meridian Health
Information provided by (Responsible Party):
Nanowear Inc.

Brief 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 5 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)

Condition or disease Intervention/treatment
Heart Failure Device: 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
Heart Failure Patients
Patients with primary diagnosis as heart failure
Device: SimpleSENSE
The Nanosense study is observational only. No interventions will be triggered by the SimpleSense device




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Exploratory comparison of signals from device to NT-proBNP [ Time Frame: 90 days per patient and till 100 Heart Failure events are observed overall. ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects of legal age to give informed consent who are currently or recently hospitalized with a primary diagnosis of heart failure
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03719079


Contacts
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Contact: John P Boehmer, M.D. 717-531-7453 jboehmer@pennstatehealth.psu.edu
Contact: Venkatesh Varadan venk@nanowearinc.com

Locations
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United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Patricia Arakelian, RN, BSN, CCRP    551-996-5722    Patricia.Arakelian@hackensackmeridian.org   
Principal Investigator: Robert Berkowitz, MD         
Sub-Investigator: Bernard Kim, MD         
Sub-Investigator: Kumar Satya, MD         
Sub-Investigator: David Silber, MD         
Sponsors and Collaborators
Nanowear Inc.
Milton S. Hershey Medical Center
Hackensack Meridian Health
Investigators
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Principal Investigator: John P Boehmer, M.D. Milton S. Hershey Medical Center

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Responsible Party: Nanowear Inc.
ClinicalTrials.gov Identifier: NCT03719079     History of Changes
Other Study ID Numbers: NWCT18-SS-001
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nanowear Inc.:
Heart Rate Variability
Heart Sounds
Fluid decompensation
Non-invasive Multi-parameter monitoring
Multi-parameter algorithm
Thoracic impedance
Respiration
Posture
Activity
Tidal Volume
Stroke Volume
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases