Heart Failure Clinical Trial
Official title:
Bayesian Hemodynamics Model for Personalized Monitoring of Congestive Heart Failure Patients - Translating Physician's Reasoning Into Computational Models, Part II
Verified date | February 2019 |
Source | Leiden University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Recruiting |
Enrollment | 20 |
Est. completion date | January 1, 2020 |
Est. primary completion date | September 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - Incomplete admission data - Cardiac asthma patients that need invasive respiratory aid |
Country | Name | City | State |
---|---|---|---|
Netherlands | Leiden University Medical Center | Leiden | Zuid Holland |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center | Philips Healthcare |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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'. | 1 year |
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