Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions

ADHF Clinical Trial

Official title:

Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02003040
• Other study ID #: STP-9000011
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 2, 2013
• Last updated: September 25, 2015
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: September 2015
• Source: Mespere Lifesciences Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to investigate the utility of Venus 1000 in predicting 30-day hospital readmissions for acute decompensated heart failure. Secondary outcomes will include correlation with NT-proBNP and weight both at admission and discharge from hospital

Description:

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and older

• Patient admitted to St. Michael's Hospital with a main clinical diagnosis of decompensated heart failure.

• Signed informed consent

Exclusion Criteria:

• Lack of patient consent.

• Presence of known AV dialysis fistula.

• Allergy to adhesive tape from Mespere Venus 1000 system.

• Known central vein stenosis.

• Ongoing photodynamic therapy.

• Assisted ventilation.

• Associated acute coronary syndrome

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• ADHF

Intervention

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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mespere Lifesciences Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in non-invasive central venous pressure (NICVP) at 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.	time of hospital admission (baseline) and time of hospital discharge	No
Secondary	NT-proBNP	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	1 visit	No
Secondary	Patient's weight	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	1 visit	No