Identification of Heart Failure Patients by Seismocardiography

Completed

• Conditions: Heart Failure

• Registration Number: NCT03656354
• Lead Sponsor: Acarix

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.

Study Timeline

• Study First Submitted: 2018-06-27
• Study Start: 2018-06-29
• Study First Submitted QC: 2018-08-31
• Study First Posted: 2018-09-04
• Primary Completion: 2022-07-27
• Study Completion: 2022-07-27
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 219

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

Exclusion criteria

1. Known atrial fibrillation
2. Acute coronary syndrome
3. Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD)
4. Implanted electronic equipment in the area above and around the heart
5. Significant operation scars, abnormal body shape, fragile or compromised skin in the seismocardiographic recording area (fourth left Inter Costal space and xiphoid process)
6. Pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Aalborg University Hospital; 🇩🇰 Aalborg, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark