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

Not Applicable

Completed

• Conditions: Impaired Left Ventricular Ejection Fraction
• Interventions: Device: Kinocardiography

• Registration Number: NCT03157115
• Lead Sponsor: Brugmann University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-16
• Study First Submitted QC: 2017-05-16
• Study First Posted: 2017-05-17
• Study Start: 2017-07-01
• Primary Completion: 2023-04-18
• Study Completion: 2023-04-18
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-04
• Last Update Posted: 2023-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Impaired left ventricular ejection fraction	Kinocardiography	Patients with reduced left ventricular ejection fraction (\< 50 %)
Control	Kinocardiography	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.

Primary Outcome Measures

Name	Time	Method
Total heart kinetic energy	1 hour	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.

Secondary Outcome Measures

Name	Time	Method
Ratio of torsional kinetic energy over total kinetic energy	1 hour	Computed according to the micro accelerations of the body at the body surface. The hypothesis is that the investigators will observe a lower ratio of torsional kinetic energy over total kinetic energy for the impaired left ventricular ejection fraction group in comparison to a paired control group.

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium