NCT03656354

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
219

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 27, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

June 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2022

Completed
Last Updated

February 28, 2023

Status Verified

February 1, 2023

Enrollment Period

4.1 years

First QC Date

June 27, 2018

Last Update Submit

February 27, 2023

Conditions

Heart Failure

Keywords

seismocardiography

Outcome Measures

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.

    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 Outcomes (4)

  • 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

  • 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

  • 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

  • Adverse events related to the CADScor seismo device.

    1 day

Interventions

SeismocardiographyDEVICE

Seismocardiography recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with clinically suspected heart failure Extension study: Patients with newly diagnosed HFrEF

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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
  • Known atrial fibrillation
  • Acute coronary syndrome
  • Implanted donor heart, mechanical heart, mechanical heart pump, pacemaker or Cardioverter Defibrillator (ICD)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Peter Søgaard, MD, DMSc

    Aalborg University Hospital

    PRINCIPAL INVESTIGATOR

  • Jacob Møller, MD, DMSc

    Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2018

First Posted

September 4, 2018

Study Start

June 29, 2018

Primary Completion

July 27, 2022

Study Completion

July 27, 2022

Last Updated

February 28, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)