Evaluation of the EasySense System in Congestive Heart Failure
1 other identifier
observational
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedFebruary 5, 2021
February 1, 2021
2 years
July 18, 2017
February 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
Implementation of EasySense device during hospitalization and daily post-discharge for thirty days.
Eligibility Criteria
This study seeks to enroll patients over the age of 21, diagnosed with congestive heart failure, who are admitted to the hospital for acute decompensated heart failure.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- National Institutes of Health (NIH)collaborator
- University of Memphiscollaborator
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Sitaramesh Emani, MD
Study Record Dates
First Submitted
July 18, 2017
First Posted
August 3, 2017
Study Start
July 1, 2017
Primary Completion
June 30, 2019
Study Completion
June 30, 2020
Last Updated
February 5, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share