Heart Failure
Conditions
Keywords
seismocardiography
Brief summary
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
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.
Interventions
DEVICESeismocardiography
Seismocardiography recording
Sponsors
Acarix
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 1. Male or female, aged 18 years or older 2. Newly diagnosed HFREF 3. Be able and willing to comply with the clinical investigational plan 4. Have signed the informed consent form
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure. | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 1 day | Count of adverse events |
Countries
Denmark
Outcome results
None listed