Wearable technology for managing heart failure
The Nanowear Wearable Heart Failure Management System Multiple Sensor Algorithm Development and Validation Trial
Nanowear Inc. · NCT03719079
This study is testing a new wearable device to see if it can help people with heart failure by predicting when their condition might get worse.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanowear Inc. (industry) |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT03719079 on ClinicalTrials.gov |
What this trial studies
The NanoSense study is an observational feasibility study aimed at developing a multi-sensor algorithm to predict worsening heart failure. It will enroll up to 500 subjects across 10 centers, collecting data on heart failure hospitalizations and various health metrics over a two-year period. Participants will wear a device called the Wearable Congestive Heart Failure Management System (WCHFS) and will be monitored for vital signs and other health indicators. The study will also involve daily self-reporting of health status by participants.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have been hospitalized for acute heart failure or discharged with a primary diagnosis of acute heart failure within the last two weeks.
Not a fit: Patients with severe aortic stenosis, unstable hemodynamics, or those unable to comply with device usage may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management and early detection of worsening heart failure in patients.
How similar studies have performed: While this approach is innovative, similar studies using wearable technology for heart failure management have shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hershey, Pennsylvania
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: John P Boehmer, M.D. — Milton S. Hershey Medical Center
- Study coordinator: John P Boehmer, M.D.
- Email: jboehmer@pennstatehealth.psu.edu
- Phone: 717-531-7453
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Fluid decompensation, Non-invasive Multi-parameter monitoring, Multi-parameter algorithm, Heart Rate Variability, Thoracic impedance, Heart Sounds, Respiration