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Completed

NCT Number: NCT03656354

Identification of Heart Failure Patients by Seismocardiography

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aalborg University Hospital, Aalborg, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Seismocardiography

Device

Seismocardiography recording

Primary outcomes

  1. Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure.

    Time frame: 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 outcomes

  1. 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

    Time frame: 1 day

  2. 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.

    Time frame: 1 day

  3. 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.

    Time frame: 1 day

  4. Adverse events related to the CADScor seismo device.

    Time frame: 1 day

    Count of adverse events

Sponsors and collaborators

Lead sponsor

Acarix

Industry

Registry information

Official study title

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

Acronym: SCG-HF

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 4, 2018
Registry last updated
Feb 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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