Development and clinical validation of a Bayesian network type model for heart failure, personalized for the individual patient, to monitor the status of heart failure.
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Laboratory outcomes:
* Na (mmol/l)
* K (mmol/L)
* eGFR (ml/min)
* serum creatinine (micromol/L)
* TSH (mu/L)
* GGT (IU/litre)
* AST (IU/litre)
* Pro BNP (ng/L)
* Lipid profile
* Hb (mmol/l)
12-lead ECG
* Heart rhythm
* Heart rate (BPM)
* QRS duration (ms)
* QRS morphology (LBBB/RBBB)
Transthoracic echocardiography
* Limitary protocol (Left Ventricular function and dimensions, Right
Ventricular function and dimensions, Mitral valve, Tricuspid valve, Inferior
Vena Cava dimensions)
X-thorax
Physical examination
* Weight (kg)
* Pulse pressure; systolic, diastolic, MAP (mmHg)
* Prominent neck veins
* Heart rhythm, manual (irregular, regular)
* Heart Sound (S3 Gallop)
* Heart murmurs: (valve insufficiency)
* Heart enlarged (apex
* SpO2 (%)
* Orthopnoea
* Dyspnoea
* Respiration rate (breaths/min)
* Pleura fluid
* Liver tender enlargement
* Nausea
* Pitting Edema (pretibial, bilateral)
* Pitting Edema (sacral when rising in the morning)
* Nocturia
Questionnaire
* *Did your weight increase last 24h, and how much? (yes/no)
* *Do you have more dyspnoea complains? (yes/no, if yes: 0-10 scale)
* *Have you noticed edema? (yes/no, if yes: 0-10 scale)
* *Do you feel fatigue? (yes/no, if yes: 0-10 scale)
* *Do you feel nauseous? (yes/no, if yes: 0-10 scale)
* *Have you contacted the hospital or your GP?* (yes/no)
Medication use
* Diuretics (kind, dosage)
* Inotropics (kind, dosage)
Secondary outcome
not applicable
Background 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.
Consequently, this has a major economic impact especially due to recurrent
admissions of these patients. When we*re in the position to predict accurately
if a patient is decompensating or not, we 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.
Study objective
Development and clinical validation of a Bayesian network type model for heart
failure, personalized for the individual patient, to monitor the status of
heart failure.
Study design
The design is a prospective cohort study.
Data of 20 hospitalized HF patients will be collected, after initiation of HF
treatment in the hospital. All observables will be collected every day during
admission.
The results of the model (interpretation of the patient data) will be compared
with one or two independent physicians interpretations of the lab values with
respect to the probability/seriousness of heart failure.
No differences in treatment of the patients will be made due this project.
Study burden and risks
During admission, this study will be no additional risk for the patient and
will not influence the treatment of the patient.
The additional burden will be minimal. It depends on the time of admission how
much additional thoracic echocardiography's will be made, to the utmost an
echocardiography will be made two times a week and once during dismiss. It
takes 20-30 minutes to perform an echocardiography. The daily questionnaire
will take 5 minutes and is partly similar to the daily anamnesis.
High Tech Campus 11, 1.140
Eindhoven 5656 AE
NL
High Tech Campus 11, 1.140
Eindhoven 5656 AE
NL
Listed location countries
Age
Inclusion criteria
In order to be included in this study, the subject is admitted to the department of cardiology in the LUMC due to congestive heart failure.
Exclusion criteria
A subject will be excluded from the study if he or she does not meet the inclusion criteria. Thus when the patient isn't admitted to the department of cardiology due to congestive heart failure.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL61810.058.17 |