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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Mespere Lifesciences Inc.
Sponsor:
Information provided by (Responsible Party):
Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier:
NCT02003040
First received: December 2, 2013
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention
ADHF
Device: Mespere Venus 1000 CVP System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions

Resource links provided by NLM:


Further study details as provided by Mespere Lifesciences Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • NT-proBNP [ Time Frame: 1 visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: September 2014
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003040

Contacts
Contact: Melissa T Perri, MESc 519-884-7575 ext 2 melissa.perri@mespere.com

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Principal Investigator: Abdul Al-Hesayen, MD         
Sub-Investigator: Juan Guillermo Duero Posada, MD         
Sponsors and Collaborators
Mespere Lifesciences Inc.
Investigators
Principal Investigator: Abdul Al-Hesayen, MD St. Michael's Hospital, Toronto
  More Information

No publications provided

Responsible Party: Mespere Lifesciences Inc.
ClinicalTrials.gov Identifier: NCT02003040     History of Changes
Other Study ID Numbers: STP-9000011
Study First Received: December 2, 2013
Last Updated: August 14, 2014
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014