Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)

Heart Failure Clinical Trial

— Echo-CRT  

Official title:

Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02986633
• Other study ID #: OBS-009
• Status: Recruiting
• Start date: December 2014
• Est. completion date: December 2025

Study information

• Verified date: July 2018
• Source: Lille Catholic University
• Contact: Amélie Lansiaux, MD , PhD
• Phone: 00 33 3 20 52 69
• Email: lansiaux.amelie[@]ghicl.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Cardiac Resynchronization Therapy
• Heart Failure

Intervention

Other:
• Echocardiography

Locations

Country	Name	City	State
France	Hospitals of Lille Catholic University (GHICL)	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in left ventricular end-systolic volume measured by echocardiography		9 months after implantation
Secondary	Death rate		2, 4, 6, 8 and 10 years after implantation
Secondary	re-hospitalisation rate		2, 4, 6, 8 and 10 years after implantation
Secondary	Changes in left ventricular ejection fraction measured by echocardiography		9 months after implantation
Secondary	Changes in left ventricular end-diastolic volume measured by echocardiography		9 months after implantation
Secondary	Changes in left ventricular longitudinal strain measured by echocardiography		9 months after implantation