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Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure (CoVa)

This study has been withdrawn prior to enrollment.
(Sponsor decided not to go forward with study. No subjects were enrolled.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02368184
First Posted: February 20, 2015
Last Update Posted: May 25, 2016
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. Read our disclaimer for details.
Collaborator:
toSense, Inc.
Information provided by (Responsible Party):
Scripps Translational Science Institute
  Purpose
The purpose of this study is to obtain observational data allowing for the preliminary assessment of the utility of a noninvasive physiologic monitor for monitoring of patients with congestive heart failure.

Condition
Congestive Heart Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure

Resource links provided by NLM:


Further study details as provided by Scripps Translational Science Institute:

Primary Outcome Measures:
  • Track physiologic parameters among patients with ADHF and explore predictive algorithms to allow for early ID of patients at risk of ADHF. [ Time Frame: 65 days ]
    • To track on a daily basis important physiologic parameters among patients with a primary diagnosis of acute decompensated heart failure (ADHF) beginning at the time of their hospitalization and then continued for up to 60 days after discharge, in order to better understand their inter- and intra- individual variability and compare this to standard monitoring including daily weights.
    • To explore the development of predictive algorithms to allow for the early identification of patients at risk of acute decompensation and/or HF hospitalization.


Secondary Outcome Measures:
  • Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology. [ Time Frame: 65 days ]
    Compare transthoracic impedance measured noninvasively with the CoVa and invasively in individuals who already have a Medtronic implanted device with OptiVol technology.


Enrollment: 0
Study Start Date: February 2015
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:
The study proposes to utilize the CoVa™ Monitoring System, a novel body-worn sensor that remotely monitors thoracic fluid, heart rate, heart rate variability, respiration rate, skin temperature, posture, and, using transmitted waveforms, stroke volume and cardiac output to evaluate the system's monitoring capabilities in individuals recently hospitalized for congestive heart failure. The data acquired through this study will play a critical roll in developing future interventional studies that will allow patients with HF to potentially receive better and more timely treatment in the home setting, decreasing hospitalizations and improving quality of life.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will be made up of adult men and women admitted to the hospital with a primary clinical diagnosis of acute decompensated heart failure. A convenience sample of 25 individuals meeting the following Inclusion criteria and have no Exclusion criteria will be enrolled.
Criteria

Inclusion Criteria:

  • Adults over age 18
  • Have wireless internet access within their homes.
  • Acute hospitalization with a primary diagnosis of acute decompensated heart failure (ADHF) diagnosed on the basis of all of the following:

    1. Symptoms:

      • Onset or worsening of dyspnea within the past 2 weeks
    2. Physical exam (at least 1 present):

      • Rales/ Crackles on auscultation
      • Elevated JVP > 8 cmH2O
      • Weight gain
      • LE edema
    3. Diagnostic imaging/ labs (at least 1 present):

      • Evidence of pulmonary congestion or edema on chest X-ray/ chest CT
      • Elevated NT-pro-BNP (age-adjusted) (>1000)
  • Patients of particular interest will be those who already have a Medtronic Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy device with the OptiVol feature that tracks transthoracic impedance.

Exclusion Criteria:

  • Allergy to ECG electrodes
  • Psychological or social situation that would make the study difficult for the patient
  • Inability to consent
  • Pregnant women
  • Pneumonia - currently, or within the past 30 days
  • Non-cardiogenic pulmonary edema (e.g. ARDS)
  • Interstitial lung disease
  • End-stage renal disease and on hemodialysis
  • For any reason unable to wear or place the CoVa™ device, e.g. pectus excavatum, fragile skin, severe arthritis.
  Contacts and Locations
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): NCT02368184


Locations
United States, California
Scripps Health
San Diego, California, United States, 92037
Sponsors and Collaborators
Scripps Translational Science Institute
toSense, Inc.
Investigators
Principal Investigator: Steven Steinhuble, MD Scripps Translational Science Institute
  More Information

Responsible Party: Scripps Translational Science Institute
ClinicalTrials.gov Identifier: NCT02368184     History of Changes
Other Study ID Numbers: 15-6537
First Submitted: February 9, 2015
First Posted: February 20, 2015
Last Update Posted: May 25, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Scripps Translational Science Institute:
noninvasive physiologic monitoring
acute decompensated heart failure (ADHF)

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases