Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)

NCT ID: NCT02986633

Last Updated: 2018-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Heart Failure Cardiac Resynchronization Therapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with heart failure and CRT

Heart failure with left ventricular ejection fraction less than 35 % treated with CRT

Echocardiography

Intervention Type OTHER

Interventions

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Echocardiography

Intervention Type OTHER

Eligibility Criteria

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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%
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lille Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvestre Maréchaux, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital of Lille Catholic University (GHICL)

Locations

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Hospitals of Lille Catholic University (GHICL)

Lomme, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Amélie Lansiaux, MD, PhD

Role: CONTACT

00 33 3 20 52 69

Facility Contacts

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Amélie Lansiaux, MD, PhD

Role: primary

00 33 3 20 52 69

References

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Layec J, Decroocq M, Delelis F, Appert L, Guyomar Y, Riolet C, Dumortier H, Mailliet A, Tribouilloy C, Marechaux S, Menet A. Dyssynchrony and Response to Cardiac Resynchronization Therapy in Heart Failure Patients With Unfavorable Electrical Characteristics. JACC Cardiovasc Imaging. 2023 Jul;16(7):873-884. doi: 10.1016/j.jcmg.2022.12.023. Epub 2023 Mar 8.

Reference Type DERIVED
PMID: 37038875 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30595180 (View on PubMed)

Other Identifiers

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OBS-009

Identifier Type: -

Identifier Source: org_study_id

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