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

NCT02368184 | Withdrawn

• 1 other identifier: 15-6537
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure

Keywords

noninvasive physiologic monitoring; acute decompensated heart failure (ADHF)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology.

  65 days

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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:
• Symptoms:
• Onset or worsening of dyspnea within the past 2 weeks
• Physical exam (at least 1 present):
• Rales/ Crackles on auscultation
• Elevated JVP \> 8 cmH2O
• Weight gain
• LE edema
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Scripps Translational Science Institute: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Scripps Health

San Diego, California, 92037, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Steven Steinhuble, MD

  Scripps Translational Science Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 20, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 25, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)