Echocardiography in Cardiac Resynchronization Therapy (Ec... | NCT02986633

Studies
Echocardiography in Cardiac Resynchronization Therapy (Echo-CRT)

NCT02986633

Sponsor

Lille Catholic University

Status

Unknown status

Last Update Posted

Jul 19, 2018Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Heart Failure
Cardiac Resynchronization Therapy

Interventions

Echocardiography

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2014

Primary Completion Date

Sep 2025Estimated

Completion Date

Dec 2025Estimated

First Submitted Date

Dec 5, 2016

First Submission Date that Met QC Criteria

Dec 6, 2016

First Posted Date

Dec 8, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 18, 2018

Last Update Posted Date

Jul 19, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with heart failure and CRT		Heart failure with left ventricular ejection fraction less than 35 % treated with CRT	Other: Echocardiography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echocardiography	Other		Patients with heart failure and CRT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in left ventricular end-systolic volume measured by echocardiography		9 months after implantation

Secondary Outcomes

Measure	Description	Time Frame
Death rate		2, 4, 6, 8 and 10 years after implantation
re-hospitalisation rate		2, 4, 6, 8 and 10 years after implantation
Changes in left ventricular ejection fraction measured by echocardiography

Other Outcomes

Not provided

Eligibility Module

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%

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with LV systolic dysfunction and QRS duration > 120 ms receiving CRT at GHICL.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Amélie Lansiaux, MD, PhD	Contact	00 33 3 20 52 69		lansiaux.amelie@ghicl.net

Overall Officials

Name	Affiliation	Role
Sylvestre Maréchaux, MD, PhD	Hospital of Lille Catholic University (GHICL)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospitals of Lille Catholic University (GHICL)	Recruiting	Lomme		59462	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37038875	Derived	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.
30595180

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases