Clinical trial NCT03656354: Identification of Heart Failure Patients by Seismocardiography
Official title: Identification of Heart Failure Patients by Seismocardiography; a Comparison With Echocardiography and Brain Natriuretic Peptide
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: seismocardiography
Lead sponsor: Acarix
Sponsor class: INDUSTRY
First posted: 2018-09-04
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with clinically suspected heart failure

Extension study:

Patients with newly diagnosed HFrEF

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.

Eligibility 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

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

Primary outcomes:
measure: Area under the receiver-operator characteristic curve, sensitivity, specificity, and positive and negative predictive value of seismocardiography in detection of heart failure.
timeFrame: 1 day
Secondary outcomes:
measure: 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
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: 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.
timeFrame: 1 day
measure: Adverse events related to the CADScor seismo device.
timeFrame: 1 day
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aalborg University Hospital
name: Peter Søgaard, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Odense University Hospital
name: Jacob Møller, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References: