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Heart FailureNCT03575533

Bayesian Hemodynamics Model for Personalized Monitoring of Congestive Heart Failure Patients

An observational study of Heart Failure, run by Leiden University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Heart failure (HF) is a serious and challenging syndrome. Globally 26 million people are living with this chronic disease and the prevalence is still increasing. Besides this growing number in prevalence, HF is also responsible for almost 1 million hospitalizations a year in the US and in Europe. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Heart Failure
What is being tested?
Bayesian network 'Sherlock'
How many people
20 participants
Where
1 siteNetherlands
Study dates
1 Jan 2019to 1 Jan 2020
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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population consists of patients who are admitted to the ward due to congestive heart failure. All patients are admitted at the department of cardiology in the LUMC.

Who may be able to join

  • At least 45 years of age
  • Able to communicate in Dutch
  • Willing and able to provide informed consent
  • Echocardiographically confirmed measurement of ejection fraction
  • Daily obtained physical exam during hospital stay
  • Lab investigations 3x / week
  • Available treatment and medication information

Who cannot join

  • Incomplete admission data
  • Cardiac asthma patients that need invasive respiratory aid

Trial locations and contacts

1 site in 1 country.

Netherlands1 site, 1 recruiting
  • Leiden University Medical Center

    Leiden, South Holland, 2333 ZA

    Tom E Biersteker, MD, +31 71 565389, t.e.biersteker@lumc.nl

    Douwe E Atsma, MD, PhD, d.e.atsma@lumc.nl

    Recruiting

Other trials in Netherlands

About this study

Official title: Bayesian Hemodynamics Model for Personalized Monitoring of Congestive Heart Failure Patients - Translating Physician's Reasoning Into Computational Models, Part II

Heart failure (HF) is a serious and challenging syndrome. Globally 26 million people are living with this chronic disease and the prevalence is still increasing. Besides this growing number in prevalence, HF is also responsible for almost 1 million hospitalizations a year in the US and in Europe. Consequently, this has a major economic impact especially due to recurrent admissions of these patients. Adequate prediction of decompensation could prevent (un)necessary admissions as a result of heart failure. Philips is developing a Bayesian Hemodynamics model for general practitioners. This model uses different observables, which can be measured at home. The outcome of the model could be used as an aid in clinical decision making in HF patients.

Read the detailed description

Heart failure (HF) is a world-wide problem. At the moment 26 million people are living with this chronic disease and the prevalence is still increasing. Besides this growing number in prevalence, HF is also responsible for almost 1 million hospitalizations a year in the US and in Europe. Consequently, this has also a major economic impact especially due to recurrent admissions of these patients. Adequate prediction of decompensation could prevent (un)necessary admissions as a result of heart failure. Philips is developing a Bayesian model for chronic heart failure, enabling monitoring of patients with heart failure in the hospital and at home. An important characteristic of such a Bayesian model is that it is a knowledge-based model, in contrast to data-mining based models, and requires only a few patient data to get started (10-20 patients). Another important characteristic is that these 'knowledge-based models' are applicable in any setting, again in contrast to data-mining based models. This makes the proposed model different from conventional data-mining approaches to modelling. During a hospital admission, the model will be "filled in" with personal patient data. Subsequently, during the rest of the hospital stay or after release from the hospital, a number of symptoms and lab measurement variables ("observables"), will be the input for the model. The output of the model (the result) will be a probability of improvement (versus worsening) of the condition of the patient or the status of the heart failure condition on a scale (from 1-10). The model can deal with less input variables than the number it has been "personalized" with. With less input measurements, naturally the reliability of the result will be reduced. This modelling approach basically captures the clinical way of thinking into a model. If interpreted in the right way using smart Bayesian modelling, the GP or geriatrician will be able to monitor and treat the majority of heart failure patients. This fits in current thinking to reduce HC costs by keeping patients at home and out of the hospital.

The clinical investigation is designed to evaluate whether the outcome of the "Bayesian Hemodynamics model" compares with the cardiologist's status assessment. The purpose of this study is to validate the computer model that has been developed to assess the status of a heart failure patient. With the model, the investigators aim to support healthcare professionals with early detection of deterioration of heart failure patients and with providing the right treatment when it is needed. If successful, this could help heart failure patients to stay at home longer and reduce hospital admissions.

The clinical literature review is documented in report, Personalized Heart Failure Monitoring using a Bayesian network, Anja v.d. Stolpe, Wim Verhaegh, Folke Noertemann, PR-TN 2017/00180.

This clinical investigation is needed, because no complete datasets, including ground truth assessments by cardiologists, are available, neither in existing databases, nor in clinical literature.

The clinical investigation needs to be performed on a population that fulfills the inclusion/exclusion criteria described in Chapter 6, because the "Bayesian Hemodynamics model" is only valid for these cases.

Conditions
Heart Failure
Being tested
Bayesian network 'Sherlock'
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bayesian network 'Sherlock'Diagnostic test

    Primary objective is to validate the Bayesian Hemodynamics model 'Sherlock'. Criterion for validation is a match between Sherlock's estimate of the Hemodynamic status of a patient and a ground truth based on a cardiologist's judgement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Validate Bayesian Hemodynamics model 'Sherlock'

    Based on all measurements of the physical examination, lab results and echocardiogram, a patient will receive a score (scale 1-10 in which 1 is no heart failure and 10 is the worst possible state) by both the cardiologist as well as 'Sherlock'.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2018
  2. Study start1 Jan 2019
  3. Primary completion1 Sep 2019 (estimated)
  4. Study completion1 Jan 2020 (estimated)

Resources

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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575533
Sponsor's protocol ID
NL61810.058.17
Status last verified
Feb 2019
First submitted
12 Jun 2018
Last updated
28 Feb 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Failure, run by Leiden University Medical Center at 1 site in Netherlands.

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 7 inclusion and 2 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 Feb 2019. 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 Netherlands. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Validate Bayesian Hemodynamics model 'Sherlock' (time frame: 1 year). 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 Feb 2019.

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