Evaluation of the EasySense System in Congestive Heart Failure

NCT ID: NCT03237923

Last Updated: 2021-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 47 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2020-06-30

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.

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.

Conditions

Congestive Heart Failure

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

EasySense device

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Memphis

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Sitaramesh Emani

Dr. Sitaramesh Emani, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Countries

United States

Other Identifiers

2016H0069

Identifier Type: -

Identifier Source: org_study_id