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AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT

Not Applicable
Recruiting
Conditions
Left Ventricular Dyssynchrony
Heart Failure
Cardiomyopathy, Dilated
Cardiac Remodeling, Ventricular
Registration Number
NCT04225520
Lead Sponsor
Universitaire Ziekenhuizen KU Leuven
Brief Summary

Previous experience with cardiac resynchronization therapy (CRT) candidates suggests that selection of these patients can be improved. Current clinical guideline approaches are mainly too unspecific and lead to a high non-responder rate of 30-40%, which causes a burden on health care systems and puts patients at risk of an unnecessary treatment who might benefit more from a conservative approach. Previous work indicated that using the assessment of mechanical dyssynchrony on echocardiography can lower the non-responder rate at least by 50% without compromising sensitivity for detecting amendable patients. The current prospective, randomized, multi-center trial was therefore designed to prove that the characterization of the mechanical properties of the left ventricle can improve patient selection for CRT. Patients will be randomized into one of two study arms: a control study arm with treatment recommendation based on clinical guidelines criteria, or an experimental study arm with treatment recommendation based on the presence of mechanical dyssynchrony. All patients will receive a CRT implantation. In the control study arm, bi-ventricular pacing will be turned on. In the experimental study arm, bi-ventricular pacing will be turned on or off, depending on the presence or absence of mechanical dyssynchrony, respectively. The primary endpoint will be non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in continuously measured LVESV per arm and the percentage 'worsened' according to the Packer Clinical Composite Score per arm after 1 year follow-up.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
700
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Volume response and Packer Clinical Composite Score12 months follow-up

Non-inferiority in outcome of a treatment recommendation based on mechanical dyssynchrony, achieved with a lower number of CRT devices implanted, effectively leading to a lower number needed to treat. Outcome measures are the average relative change in left ventricular end-systolic volume and the proportion of patients 'worsened' according to the Packer Clinical Composite Score after 12 months follow-up.

Secondary Outcome Measures
NameTimeMethod
Difference in predictive value for volume response12 months follow-up

≥15% relative reduction in left ventricular end-systolic volume from baseline to month 12 will be considered as a response

Difference in long-term patient outcome in both arms3 years and 5 years follow-up

* Kaplan Meier survival analysis for heart failure hospitalization

* Kaplan Meier survival analysis for cardiovascular mortality

* Kaplan Meier survival analysis for combined heart failure hospitalization and cardiovascular mortality

* Kaplan Meier survival analysis for all-cause mortality

Effect on left ventricular function in both arms12 months follow-up

* ≥ 10% difference in relative change in left ventricular ejection fraction and/or

* ≥1.5% difference in absolute change in global longitudinal strain and/or

* improvement in myocardial work from baseline to month 12

Difference in predictive value for long-term patient outcome in both arms1 year, 3 years and 5 years follow-up

Cox's proportional hazards model:

* At 1 year for 'worsened' PCCS

* At 3 and 5 years for cardiovascular mortality and heart failure hospitalization

Difference in quality of life as measured by the Minnesota Living with Heart Failure questionnaire score and EuroQol 5D index score in both arms12 months follow-up

* ≥ 5 points difference in change on the Minnesota Living with Heart Failure questionnaire score and/or

* ≥0.08 points difference in change on the EuroQol 5D index score from baseline to month 12

Difference in 6 minute walk test distance in both arms12 months follow-up

≥ 45 meters difference in change from baseline to month 12

Trial Locations

Locations (24)

University Hospital Antwerp

🇧🇪

Antwerp, Belgium

ZNA Middelheim

🇧🇪

Antwerp, Belgium

AZ Sint-Jan Brugge

🇧🇪

Brugge, Belgium

AZ Maria Middelares

🇧🇪

Ghent, Belgium

Ghent University Hospital

🇧🇪

Ghent, Belgium

UZ Leuven

🇧🇪

Leuven, Belgium

AZ Damiaan

🇧🇪

Ostend, Belgium

AZ Delta

🇧🇪

Roeselare, Belgium

Dante Pazzanese Institute of Cardiology

🇧🇷

São Paulo, Brazil

CHRU Brest

🇫🇷

Brest, France

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University Hospital Antwerp
🇧🇪Antwerp, Belgium
Johanna Seghers
Contact
Nathalie Brosens
Contact
Johan Saenen, MD, PhD
Principal Investigator

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