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Clinical Trials/NCT02986633
NCT02986633
Recruiting
Not Applicable

Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods

Lille Catholic University1 site in 1 country1,000 target enrollmentDecember 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Lille Catholic University
Enrollment
1000
Locations
1
Primary Endpoint
Changes in left ventricular end-systolic volume measured by echocardiography
Status
Recruiting
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2014
End Date
December 2025
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Lille Catholic University
Responsible Party
Sponsor

Eligibility Criteria

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%

Outcomes

Primary Outcomes

Changes in left ventricular end-systolic volume measured by echocardiography

Time Frame: 9 months after implantation

Secondary Outcomes

  • 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)

Study Sites (1)

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