ADHFNCT02003040
Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions
An observational study of ADHF, run by Mespere Lifesciences Inc. at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ADHF
- What is being tested?
- Mespere Venus 1000 CVP System
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure.
Who may be able to join
- Age 18 and older
- Patient admitted to St. Michael's Hospital with a main clinical diagnosis of decompensated heart failure.
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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.
- Conditions
- ADHF
- Being tested
- Mespere Venus 1000 CVP System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mespere Venus 1000 CVP SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Mespere Venus 1000 CVP System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: time of hospital admission (baseline) and time of hospital discharge
Secondary outcomes (2)
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
Measured: 1 visit
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
Measured: 1 visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startSep 2014
- Primary completionApr 2016 (estimated)
- Study completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHFStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mespere Lifesciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abdul Al-Hesayen, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003040
- Sponsor's protocol ID
- STP-9000011
- Status last verified
- Sep 2015
- First submitted
- 2 Dec 2013
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Mespere Venus 1000 in Predicting Heart Failure Hospital Readmissions
- ClinicalTrials.gov ID
- NCT02003040
- Acronym / sponsor ID
- STP-9000011
- Conditions
- ADHF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mespere Lifesciences Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| St. Michael's Hospital Patients | – | Device: Mespere Venus 1000 CVP SystemPatients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Cardiology ward at St Michael's Hospital with a main diagnosis of acute decompensated heart failure.
Key inclusion criteria (3 listed)
- Age 18 and older
- Patient admitted to St. Michael's Hospital with a main clinical diagnosis of decompensated heart failure.
- Signed informed consent
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mespere Venus 1000 CVP SystemAn 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. | Device | St. Michael's Hospital Patients |
Primary outcome
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.
2 secondary outcomes
NT-proBNP
Time frame: 1 visit
Patient's weight
Time frame: 1 visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
Related trials for ADHF
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Al-Hesayen, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHF, run by Mespere Lifesciences Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.