Evaluation of the EasySense System in Congestive Heart Failure

Congestive Heart Failure Clinical Trial

Official title:

Evaluation of the EasySense System in Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03237923
• Other study ID #: 2016H0069
• Status: Completed
• Start date: July 1, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: February 2021
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The EasySense device is a non-invasive device designed to measure lung fluid in patients with Congestive Heart Failure (CHF). This study seeks to evaluate the efficacy of the EasySense system in measuring lung fluid volume.

Description:

Across the globe, Congestive Heart Failure (CHF) continues to be the leading cause of mortality and hospitalizations in the 21st century. Despite advancements, prognosis often remains poor and mortality high. Congestive Heart Failure diagnoses are often characterized by frequent hospitalizations and re-admissions, and early detection of pulmonary edema, a chief characteristic of worsening heart failure, may have positive implications in patients' quality of life and frequency of hospitalizations. The EasySense device is a non-invasive device designed to measure lung fluid in patients with CHF. Similar to ultrasound technology, the device uses radiofrequency waves to assess fluid status. The device is placed on the bare skin of the chest and held in place for approximately 60 seconds to obtain a reading. This study seeks to evaluate the efficacy of the EasySense system in measuring lung fluid volume. Seventy-five patients are sought for enrollment. Patients will be enrolled during their hospital stay, and will be asked to maintain daily EasySense measurements, in addition to other measurements, for thirty days post-discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Current hospitalization for acute decompensated heart failure requiring IV diuretics or vasoactive drugs
• NYHA class II-IV
• Willing and able to participate in index and follow-up measurements
• Able to speak, read, and write in English
• Knows how to use a smartphone
• Preference for patients who undergo a right heart catheterization or continuous pulmonary artery monitoring upon admission or during hospitalization

Exclusion Criteria:

• Current or planned treatments with any inotropic agents or mechanical support (LVAD, intra-aortic balloon pump, invasive mechanically assisted ventilation) at time of enrollment
• Requiring demand pacing
• Prior heart transplant
• End-stage renal disease on hemodialysis
• Physical deformities in the thorax area that may prevent proper application of EasySense device, as assessed by investigator
• Sign of local rib cage or thoracic lesion or any illness which may be aggravated or cause significant discomfort from application of EasySense device, as assessed by investigator
• Pregnancy or lactation

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• EasySense device
Implementation of EasySense device during hospitalization and daily post-discharge for thirty days.

Locations

Country	Name	City	State
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Ohio State University	National Institutes of Health (NIH), University of Memphis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of volume status to EasySense measurements	Patient volume status extracted from medical records will be compared to what the EasySense device measures.	30 days