Clinical trial NCT02368184: Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure
Official title: Pilot Study of the CoVa™ Monitoring of Patients With Congestive Heart Failure
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Congestive Heart Failure
Keywords: noninvasive physiologic monitoring
acute decompensated heart failure (ADHF)
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2015-02-20
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Track physiologic parameters among patients with ADHF and explore predictive algorithms to allow for early ID of patients at risk of ADHF.
timeFrame: 65 days
Secondary outcomes:
measure: Compare transthoracic impedance in individuals who already have a Medtronic implanted device with OptiVol technology.
timeFrame: 65 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Scripps Health
state: California
Study officials:
affiliation: Scripps Translational Science Institute
name: Steven Steinhuble, MD
role: PRINCIPAL_INVESTIGATOR
References: