Heart Failure Clinical Trial

Evaluation of the EasySense System in Congestive Heart Failure

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.

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Full 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.

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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

Study is for people with:

Heart Failure

Estimated Enrollment:

47

Study ID:

NCT03237923

Recruitment Status:

Completed

Sponsor:

Ohio State University

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There is 1 Location for this study

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The Ohio State University Wexner Medical Center
Columbus Ohio, 43210, United States

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Study is for people with:

Heart Failure

Estimated Enrollment:

47

Study ID:

NCT03237923

Recruitment Status:

Completed

Sponsor:


Ohio State University

How clear is this clinincal trial information?

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