Validation of Kinocardiography, New Technology for Cardiac Linear and Torsional Contractility Measurement, to Assess Heart Failure Patient With Low Ejection Fraction

NCT03157115 | Completed

• 1 other identifier: CHUB-Kino-HFrEF
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Measuring cardiac contractility is commonly realized with gold standard echocardiography or MRI. Portable devices to measure this contractility are not available as for rhythm and electric function assessment. The new Kinocardiography technology could provide a non invasive and portable tool to measure contractility. This device records the electric and mechanic function of the heart simultaneously. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow the investigators to calculate parameters such as kinetics energies related to cardiac contractility. Kinocardiography is a non invasive and portable technology.

Conditions

Impaired Left Ventricular Ejection Fraction

Keywords

Kinocardiography; Cardiac contractility; Heart kinetic energy

Outcome Measures

Primary Outcomes (1)

• Total heart kinetic energy

  Computed according to the micro accelerations of the body at the body surface. The hypothesis is that the investigators will observe a lower total heart kinetic energy for the group with impaired left ventricular ejection fraction in comparison to a paired control patient group.

  1 hour

Secondary Outcomes (1)

• Ratio of torsional kinetic energy over total kinetic energy

  1 hour

Study Arms (2)

Impaired left ventricular ejection fraction

EXPERIMENTAL

Patients with reduced left ventricular ejection fraction (\< 50 %)

Device: Kinocardiography

Control

ACTIVE COMPARATOR

Patients with a normal left ventricular ejection fraction (≥ 50 %), without heart failure. The patients from the reduced left ventricular ejection fraction group will be matched with patients from the control group for sex, age, BMI and cardiovascular treatment.

Device: Kinocardiography

Interventions

Kinocardiography DEVICE

This device records the electric and mechanic function of the heart. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow us to calculate parameters such as kinetics energies related to cardiac contractility. During a standard echocardiography appointment for a patient suffering from a cardiovascular condition with/without heart failure, the cardiologist will monitor the heart of the patient with the Kino device (examination lasting a few minutes with the patient lying down on a bed). Data will be matched between the control group and the experimental group.

Control; Impaired left ventricular ejection fraction

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Control group: Left Ventricle Ejection Fraction ≥ 50 %
• Heart failure patients: Left Ventricle Ejection Fraction \< 50 %

You may not qualify if:

• Intracardiac devices and arrhythmia at the time of assessment
• Participates in other clinical study or trial.

Sponsors & Collaborators

• Brugmann University Hospital: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

Related Publications (1)

• De Keyzer E, Hossein A, Rabineau J, Morissens M, Almorad A, van de Borne P. Non-invasive cardiac kinetic energy distribution: a new marker of heart failure with impaired ejection fraction (KINO-HF). Front Cardiovasc Med. 2023 May 2;10:1096859. doi: 10.3389/fcvm.2023.1096859. eCollection 2023.

  PMID: 37200972 DERIVED

Study Officials

• Eva De Keyzer, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: July 1, 2017
• Primary Completion: April 18, 2023
• Study Completion: April 18, 2023
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)