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

Congestive Heart Failure Clinical Trial

— CoVa  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02368184
• Other study ID #: 15-6537
• Status: Withdrawn
• Phase: N/A
• First received: February 9, 2015
• Last updated: May 23, 2016
• Start date: February 2015
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Scripps Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Locations

Country	Name	City	State
United States	Scripps Health	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Scripps Translational Science Institute	toSense, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No