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

Withdrawn before enrolling

Conditions studied: Congestive Heart Failure

In brief

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.

Key facts

Study ID

NCT02368184

Run by

Scripps Translational Science Institute

People needed

0

Starts

2015-02-01

Expected to finish

2016-05-01

Last updated by the study team

2016-05-25

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Scripps Health — San Diego, California, United States

Full record on ClinicalTrials.gov

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