Identification of Heart Failure Patients by Seismocardiography

Heart Failure Clinical Trial

— SCG-HF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656354
• Other study ID #: AC013AOU
• Status: Completed
• Start date: June 29, 2018
• Est. completion date: July 27, 2022

Study information

• Verified date: February 2023
• Source: Acarix
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: July 27, 2022
• Est. primary completion date: July 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Seismocardiography
Seismocardiography recording

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Acarix

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Adverse events related to the CADScor seismo device.	Count of adverse events	1 day