Identification of Heart Failure Patients by Seismocardiography

Study Overview
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Brief Summary
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The aim of the current study is to develop and validate an algorithm based on seismocardiography recordings to detect heart failure. Echocardiography will be used as the golden standard for defining patients with heart failure.

Detailed Description
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Seismocardiography is inspired from methods for the analysis of seismic activity and can be used to describe the heart's movements using a specially developed sensor placed on the patient's chest. The project aims to describe the motion of the heart using automated computer analysis of the seismocardiography signal for development of a simple method for the analysis of myocardial performance.

Official Title
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Identification of Heart Failure Patients by Seismocardiography; a Comparison With Echocardiography and Brain Natriuretic Peptide

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Seismocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18 years or older Clinically suspected heart failure, and referred to an outpatient clinic Be able and willing to comply with the clinical investigational plan Have signed the informed consent form Exclusion Criteria: Known HF Known atrial fibrillation Acute coronary syndrome Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD) Implanted electronic equipment in the area above and around the heart Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process) Pregnancy Extension study: Inclusion criteria Male or female, aged 18 years or older Newly diagnosed HFREF Be able and willing to comply with the clinical investigational plan Have signed the informed consent form Exclusion criteria Known atrial fibrillation Acute coronary syndrome Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD) Implanted electronic equipment in the area above and around the heart Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process) Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Seismocardiography|Seismocardiography recording|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure. | Heart failure defined as heart failure with reduced ejection fraction, heart failure with mid-range ejection fraction and heart failure with preserved ejection fraction combined. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography and NT-proBNP, respectively, in detection of heart failure with reduced ejection fraction |  | 1 day | 
| Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure with mid-range ejection fraction. |  | 1 day | 
| Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure with preserved ejection fraction. |  | 1 day | 
| Adverse events related to the CADScor seismo device. | Count of adverse events | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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seismocardiography