Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)

Recruiting

• Conditions: Cardiac Resynchronization Therapy; Heart Failure
• Interventions: Other: Echocardiography

• Registration Number: NCT02986633
• Lead Sponsor: Lille Catholic University

Brief Summary

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

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 Timeline

• Study Start: 2014-12
• Study First Submitted: 2016-12-05
• Study First Submitted QC: 2016-12-06
• Study First Posted: 2016-12-08
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-19
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with heart failure and CRT	Echocardiography	Heart failure with left ventricular ejection fraction less than 35 % treated with CRT

Primary Outcome Measures

Name	Time	Method
Changes in left ventricular end-systolic volume measured by echocardiography	9 months after implantation

Secondary Outcome Measures

Name	Time	Method
Changes in left ventricular longitudinal strain measured by echocardiography	9 months after implantation
re-hospitalisation rate	2, 4, 6, 8 and 10 years after implantation
Death 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

Trial Locations

Locations (1)

Hospitals of Lille Catholic University (GHICL); 🇫🇷 Lomme, France