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

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.

Study Overview

• Status: Withdrawn
• Conditions: Congestive Heart Failure

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92037
      • Scripps Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Track physiologic parameters among patients with ADHF and explore predictive algorithms to allow for early ID of patients at risk of ADHF.	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.	65 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology.	Compare transthoracic impedance measured noninvasively with the CoVa and invasively in individuals who already have a Medtronic implanted device with OptiVol technology.	65 days

Collaborators and Investigators

• Sponsor: Scripps Translational Science Institute
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Steven Steinhuble, MD, Scripps Translational Science Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: February 9, 2015
• First Submitted That Met QC Criteria: February 12, 2015
• First Posted (Estimate): February 20, 2015

Study Record Updates

• Last Update Posted (Estimate): May 25, 2016
• Last Update Submitted That Met QC Criteria: May 23, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: noninvasive physiologic monitoring; acute decompensated heart failure (ADHF)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 15-6537

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO