Clinical trial NCT02986633: Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)
Official title: Prediction of Response to Cardiac Resynchronization Therapy by New Echocardiographic Methods
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure
Cardiac Resynchronization Therapy
Keywords: Cardiac Resynchronization Therapy
Echocardiography
Biventricular Pacing
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with LV systolic dysfunction and QRS duration \> 120 ms receiving CRT at GHICL.

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.

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%

Primary outcomes:
measure: Changes in left ventricular end-systolic volume measured by echocardiography
timeFrame: 9 months after implantation
Secondary outcomes:
measure: Death rate
timeFrame: 2, 4, 6, 8 and 10 years after implantation
measure: re-hospitalisation rate
timeFrame: 2, 4, 6, 8 and 10 years after implantation
measure: Changes in left ventricular ejection fraction measured by echocardiography
timeFrame: 9 months after implantation
measure: Changes in left ventricular end-diastolic volume measured by echocardiography
timeFrame: 9 months after implantation
measure: Changes in left ventricular longitudinal strain measured by echocardiography
timeFrame: 9 months after implantation
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hospitals of Lille Catholic University (GHICL)
Study officials:
affiliation: Hospital of Lille Catholic University (GHICL)
name: Sylvestre Maréchaux, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.