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

NCT ID: NCT03157115

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-01
• Study Completion Date: 2023-04-18

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Impaired left ventricular ejection fraction

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

Group Type: EXPERIMENTAL

Kinocardiography

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Kinocardiography

Intervention Type: 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.

Interventions

Kinocardiography

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brugmann University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr Marielle Morissens

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eva De Keyzer, MD

Role: PRINCIPAL_INVESTIGATOR

CHU Brugmann

Locations

CHU Brugmann

Brussels, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 37200972 (View on PubMed)

Other Identifiers

CHUB-Kino-HFrEF

Identifier Type: -

Identifier Source: org_study_id