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

NCT ID: NCT02368184

Last Updated: 2016-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-05-31

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.

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.

Conditions

Congestive Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

Scripps Translational Science Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Steinhuble, MD

Role: PRINCIPAL_INVESTIGATOR

Scripps Translational Science Institute

Locations

Scripps Health

San Diego, California, United States

Countries

United States

Other Identifiers

15-6537

Identifier Type: -

Identifier Source: org_study_id