Clinical trial NCT02003040: Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions
Official title: Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ADHF
Lead sponsor: Mespere Lifesciences Inc.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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

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 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

Primary outcomes:
measure: Change from baseline in non-invasive central venous pressure (NICVP) at time of hospital discharge
timeFrame: time of hospital admission (baseline) and time of hospital discharge
Secondary outcomes:
measure: NT-proBNP
timeFrame: 1 visit
measure: Patient's weight
timeFrame: 1 visit
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Abdul Al-Hesayen, MD
role: PRINCIPAL_INVESTIGATOR
References: