Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 898 for:    Recruiting, Not yet recruiting, Available Studies | Congestive heart failure
Previous Study | Return to List | Next Study

Evaluation of the EasySense System in Congestive Heart Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03237923
Recruitment Status : Recruiting
First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
University of Memphis
Information provided by (Responsible Party):
Sitaramesh Emani, Ohio State University

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
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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Evaluation of the EasySense System in Congestive Heart Failure
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


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


Primary Outcome Measures :
  1. Comparison of volume status to EasySense measurements [ Time Frame: 30 days ]
    Patient volume status extracted from medical records will be compared to what the EasySense device measures.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237923


Contacts
Layout table for location contacts
Contact: Sitaramesh Emani, MD 614.293.4299 sitaramesh.emani@osumc.edu
Contact: Christina Athas, MPH christina.athas@osumc.edu

Locations
Layout table for location information
United States, Ohio
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Christina Athas, MPH       christina.athas@osumc.edu   
Contact: Brittany Monk       brittany.monk@osumc.edu   
Principal Investigator: Sitaramesh Emani, MD         
Sponsors and Collaborators
Ohio State University
National Institutes of Health (NIH)
University of Memphis

Layout table for additonal information
Responsible Party: Sitaramesh Emani, Dr. Sitaramesh Emani, MD, Ohio State University
ClinicalTrials.gov Identifier: NCT03237923     History of Changes
Other Study ID Numbers: 2016H0069
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sitaramesh Emani, Ohio State University:
fluid
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases