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This study has been withdrawn prior to enrollment.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:

Collaborator:

toSense, Inc.

Information provided by (Responsible Party):

Scripps Translational Science Institute

ClinicalTrials.gov Identifier:

NCT02368184

First received: February 9, 2015

Last updated: May 23, 2016

Last verified: May 2016

History of Changes

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:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

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


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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	February 9, 2015
Last Updated:	May 23, 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

ClinicalTrials.gov processed this record on August 16, 2017

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