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Identification of Heart Failure Patients by Seismocardiography (SCG-HF)

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ClinicalTrials.gov Identifier: NCT03656354
Recruitment Status : Recruiting
First Posted : September 3, 2018
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Heart Failure Device: Seismocardiography

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Heart Failure Patients by Seismocardiography; a Comparison With Echocardiography and Brain Natriuretic Peptide
Actual Study Start Date : June 29, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure


Intervention Details:
  • Device: Seismocardiography
    Seismocardiography recording


Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with clinically suspected heart failure
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656354


Contacts
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Contact: Marianne Nørskov, M.Sc, PhD +45 3119 6977 dkmsn@acarix.com

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Peter Søgaard, MD, DMSc         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Jacob Møller, MD, DMSc         
Sponsors and Collaborators
Acarix
Investigators
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Principal Investigator: Peter Søgaard, MD, DMSc Aalborg Universitetshospital
Principal Investigator: Jacob Møller, MD, DMSc Odense University Hospital

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Responsible Party: Acarix
ClinicalTrials.gov Identifier: NCT03656354     History of Changes
Other Study ID Numbers: AC013AOU
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acarix:
seismocardiography

Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases