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

• ClinicalTrials.gov Identifier: NCT02368184
• Recruitment Status: Withdrawn
• First Posted: February 20, 2015
• Last Update Posted: May 25, 2016
• Sponsor: Scripps Translational Science Institute
• Collaborator: toSense, Inc.
• Information provided by (Responsible Party): Scripps Translational Science Institute

Study Description

Brief Summary:

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 or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure
• Study Start Date: February 2015
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 15-6537
• 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