Identification of Heart Failure Patients by Seismocardiography

NCT ID: NCT03656354

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-29

Study Completion Date

2022-07-27

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.

Conditions

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Heart Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Seismocardiography

Seismocardiography recording

Intervention Type DEVICE

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


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

* 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:


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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acarix

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Søgaard, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Aalborg University Hospital

Jacob Møller, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Odense University Hospital

Locations

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Aalborg University Hospital

Aalborg, , Denmark

Site Status

Odense University Hospital

Odense, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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AC013AOU

Identifier Type: -

Identifier Source: org_study_id

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