Evaluation of the EasySense System in Congestive Heart Failure

Sponsor

Ohio State University (Other)

Overall Status

Completed

CT.gov ID

NCT03237923

Collaborator

National Institutes of Health (NIH) (NIH), University of Memphis (Other)

Enrollment

Location

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Congestive Heart Failure	Device: EasySense device

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

47 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Evaluation of the EasySense System in Congestive Heart Failure

Actual Study Start Date :

Jul 1, 2017

Actual Primary Completion Date :

Jun 30, 2019

Actual Study Completion Date :

Jun 30, 2020

Outcome Measures

Primary Outcome Measures

Comparison of volume status to EasySense measurements [30 days]
Patient volume status extracted from medical records will be compared to what the EasySense device measures.

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

Ohio State University
National Institutes of Health (NIH)
University of Memphis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sitaramesh Emani, Dr. Sitaramesh Emani, MD, Ohio State University

ClinicalTrials.gov Identifier:

NCT03237923

Other Study ID Numbers:

2016H0069

First Posted:

Aug 3, 2017

Last Update Posted:

Feb 5, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sitaramesh Emani, Dr. Sitaramesh Emani, MD, Ohio State University

fluid

Additional relevant MeSH terms:

Heart Failure

Study Results

No Results Posted as of Feb 5, 2021