Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions
|ClinicalTrials.gov Identifier: NCT02003040|
Recruitment Status : Unknown
Verified September 2015 by Mespere Lifesciences Inc..
Recruitment status was: Enrolling by invitation
First Posted : December 6, 2013
Last Update Posted : September 28, 2015
|Condition or disease||Intervention/treatment|
|ADHF||Device: Mespere Venus 1000 CVP System|
Rehospitalizations for heart failure have been linked to poor clinical outcomes, rates remain high despite different attempts to decrease them . Clinical indicators of volume congestion at time of discharge are associated with increased rates of readmission . Clinical evaluation of volume status remains the gold standard in determination of readiness and timing of hospital discharge, however identification of persistent congestion might prove difficult .
Assessment of the right atrial pressure can be done non-invasively at the bedside; however, precision and accuracy of this method are variable . Echocardiography is a valuable tool in the estimation of elevated central pressure , this, however is time consuming and requires trained personnel. While invasive measurements provide accurate estimation of central venous pressure, it is an impractical approach in most patients, notwithstanding the risks associated with the insertion of a catheter into the central circulation .
Since a significant proportion of readmitted patients return to hospital with congestive symptoms, attempts have been made to improve our ability to assess volume status . Current clinical evidence suggests that BNP-guided management of patients with congestive heart failure can decrease all-cause mortality and heart failure rehospitalization. However, biological variation for natriuretic peptides is high , and optimal targets are difficult to determine in individual patients.
The Mespere Venus 1000 system is a non-invasive tool that has previously shown reliable correlation and accuracy with central venous pressure obtained invasively in the catheterization laboratory and good correlation with jugular venous pressure at the bedside.
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||May 2016|
St. Michael's Hospital Patients
Patients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure
Device: Mespere Venus 1000 CVP System
An adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject. A CVP measurement is recorded at time of patient's hospital admission and discharge. CVP readings will remain concealed from the treating team.
- Change from baseline in non-invasive central venous pressure (NICVP) at time of hospital discharge [ Time Frame: time of hospital admission (baseline) and time of hospital discharge ]To determine if NICVP (taken at time of hospital admission and discharge) from the Mespere Venus 1000 CVP System can predict 30-day hospital readmissions for acute decompensated heart failure.
- NT-proBNP [ Time Frame: 1 visit ]To investigate if there's a correlation between CVP measurements from the Mespere Venus 1000 CVP System and NT-proBNP at time of hospital admission and discharge
- Patient's weight [ Time Frame: 1 visit ]To investigate if there's a correlation between CVP measurements from the Mespere Venus 1000 CVP System and weight change at time of hospital admission and discharge
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003040
|St. Michael's Hospital|
|Toronto, Ontario, Canada, M5B 1W8|
|Principal Investigator:||Abdul Al-Hesayen, MD||St. Michael's Hospital, Toronto|