Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT) (Echo-CRT)

Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods

The present observational prospective study aims at identifying echocardiographic parameters (based on the Left Bundle Branch Block (LBBB)-like contraction of the left ventricle (LV) ascertained using new methods of echocardiography including speckle tracking strain) that are linked to Cardiac Resynchronization Therapy (CRT) response and a better outcome following CRT

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiac Resynchronization Therapy
• Intervention / Treatment: Other: Echocardiography

Detailed Description

The Cardiac Resynchronization Therapy (CRT) reduces mortality of patients with heart failure and reduced LV ejection fraction. The clinical benefit of CRT is mediated by LV reverse remodelling (decrease in LV end-systolic volume over time). However, 30 to 50 % of these patients will not experience LV reverse remodelling following CRT.

Classical parameters of dyssynchrony obtained by conventional methods of echocardiography (including doppler tissue imaging) have a limited value in predicting CRT response. Meanwhile, patients with a Left Bundle Branch Block (LBBB) on the electrocardiogram experience more frequently LV reverse remodelling than those without a LBBB.

LBBB is responsible for specific LV contractile abnormalities that can be identified by speckle tracking strain echocardiography (early septal contraction, stretching of late contraction of the postero-lateral wall). The predictive value of these abnormalities remains to be studied.

Thus, it has been hypothesised that these LBBB-related contractile abnormalities may be independent predictors of LV reverse remodelling and outcome following CRT.

The present observational prospective study aims at identifying echocardiographic parameters (based on the LBBB-like contraction of the LV ascertained using new methods of echocardiography including speckle tracking strain) that are linked to CRT response and a better outcome following CRT.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Amélie Lansiaux, MD, PhD; Phone Number: 00 33 3 20 52 69; Email: lansiaux.amelie@ghicl.net

Study Locations

• France
  • Lomme, France, 59462
    • Recruiting
    • Hospitals of Lille Catholic University (GHICL)
    • Contact: Amélie Lansiaux, MD, PhD; Phone Number: 00 33 3 20 52 69; Email: lansiaux.amelie@ghicl.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with LV systolic dysfunction and QRS duration > 120 ms receiving CRT at GHICL.

Description

Inclusion Criteria:

• Heart failure with left ventricular ejection fraction less than 35 %
• QRS duration over than 120 ms
• Clinical indication for CRT

Exclusion Criteria:

• Rythmologic indication of CRT for atrial fibrillation control
• Rythmologic indication of CRT for left ventricular ejection fraction between 35% and 45%

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with heart failure and CRT; Heart failure with left ventricular ejection fraction less than 35 % treated with CRT	Other: Echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in left ventricular end-systolic volume measured by echocardiography	9 months after implantation

Secondary Outcome Measures

Outcome Measure	Time Frame
Death rate	2, 4, 6, 8 and 10 years after implantation
re-hospitalisation rate	2, 4, 6, 8 and 10 years after implantation
Changes in left ventricular ejection fraction measured by echocardiography	9 months after implantation
Changes in left ventricular end-diastolic volume measured by echocardiography	9 months after implantation
Changes in left ventricular longitudinal strain measured by echocardiography	9 months after implantation

Collaborators and Investigators

• Sponsor: Lille Catholic University
• Investigators: Principal Investigator: Sylvestre Maréchaux, MD, PhD, Hospital of Lille Catholic University (GHICL)

Publications and helpful links

General Publications

• Appert L, Menet A, Altes A, Ennezat PV, Bardet-Bouchery H, Binda C, Guyomar Y, Delelis F, Castel AL, Le Goffic C, Guerbaai RA, Graux P, Tribouilloy C, Marechaux S. Clinical Significance of Electromechanical Dyssynchrony and QRS Narrowing in Patients With Heart Failure Receiving Cardiac Resynchronization Therapy. Can J Cardiol. 2019 Jan;35(1):27-34. doi: 10.1016/j.cjca.2018.10.019. Epub 2018 Nov 14.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): September 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 5, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimate): December 8, 2016

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Cardiac Resynchronization Therapy; Echocardiography; Biventricular Pacing
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: OBS-009