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AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT

NCT ID: NCT04225520

Last Updated: 2023-12-06

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

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2030-12-01

Brief Summary

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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

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Conditions

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Left Ventricular Dyssynchrony Heart Failure Cardiomyopathy, Dilated Cardiac Remodeling, Ventricular

Keywords

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Cardiac resynchronization therapy Heart failure Mechanical dyssynchrony Echocardiography Apical rocking Septal flash Left ventricle

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Treatment recommendation based on guidelines

Treatment of the patient assigned to this arm will be based on the current guidelines for CRT implantation, as issued by the European Society of Cardiology. All patients will receive CRT implantation, with bi-ventricular pacing ON.

Group Type ACTIVE_COMPARATOR

Cardiac resynchronization therapy ON

Intervention Type DEVICE

Implantation of a CRT device. Bi-ventricular pacing will be turned ON.

Treatment recommendation based on mechanical dyssynchrony

Treatment of the patients assigned to this arm will be based on the presence of mechanical dyssynchrony. All patients will receive CRT implantation. Bi-ventricular pacing will be either turned ON or OFF, based on respectively the presence or absence of mechanical dyssynchrony.

Group Type EXPERIMENTAL

Cardiac resynchronization therapy ON

Intervention Type DEVICE

Implantation of a CRT device. Bi-ventricular pacing will be turned ON.

Cardiac resynchronization therapy OFF

Intervention Type DEVICE

Implantation of a CRT device. Bi-ventricular pacing will be turned OFF.

Interventions

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Cardiac resynchronization therapy ON

Implantation of a CRT device. Bi-ventricular pacing will be turned ON.

Intervention Type DEVICE

Cardiac resynchronization therapy OFF

Implantation of a CRT device. Bi-ventricular pacing will be turned OFF.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient has a LVEF ≤ 35%
* Patient has a LVEDD ≥ 2.7cm/m² or LVEDD ≥ 50mm (m) and ≥45mm (f)
* Patient has been in a stable medical condition for ≥ 1 month prior inclusion
* Patient underwent complete revascularization in case of ischemia
* Patients is able to understand and willing to provide a written informed consent
* Patient is 18 years or older

Exclusion Criteria

Patients with the following conditions will be excluded:

* unreliable left ventricular volume measurements
* severe MR or more than moderate other valvular disease
* pulmonary hypertension, other than secondary to left heart disease
* patient on hemodialysis
* life expectancy \< 1 year
* pregnant or breastfeeding

Patients with prior right ventricular pacing between 20% to 80% will be excluded.

Patients with prior right ventricular pacing ≤ 20% or no pacemaker / ICD will be excluded if they have any of the following criteria:

* PR duration \> 250ms
* second / third degree atrioventricular block
* intrinsic QRS duration \< 130ms
* atrial fibrillation with resting HR \< 50/min or \> 80/min

Patients with prior right ventricular pacing ≥ 80% will be excluded if they have any of the following criteria:

* sensed AV delay \> 250ms
* paced AV delay \> 280ms

Patients with a prior pacemaker / ICD scheduled for LBBaP will be excluded regardless of pacing percentage
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Jens-Uwe Voigt, MD, PhD

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jens-Uwe Voigt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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University Hospital Antwerp

Antwerp, , Belgium

Site Status RECRUITING

ZNA Middelheim

Antwerp, , Belgium

Site Status RECRUITING

AZ Sint-Jan Brugge

Bruges, , Belgium

Site Status RECRUITING

AZ Maria Middelares

Ghent, , Belgium

Site Status RECRUITING

Ghent University Hospital

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven

Leuven, , Belgium

Site Status RECRUITING

AZ Damiaan

Ostend, , Belgium

Site Status RECRUITING

AZ Delta

Roeselare, , Belgium

Site Status RECRUITING

Dante Pazzanese Institute of Cardiology

São Paulo, , Brazil

Site Status RECRUITING

CHRU Brest

Brest, , France

Site Status RECRUITING

Groupements des hôpitaux de l'institut catholique de Lille

Lille, , France

Site Status RECRUITING

CHU Rennes - Pontchaillou Hospital

Rennes, , France

Site Status RECRUITING

St. Vinzenz-Hospital

Cologne, , Germany

Site Status RECRUITING

Universitätsmedizin Rostock

Rostock, , Germany

Site Status RECRUITING

Universitätsklinikum Würzburg

Würzburg, , Germany

Site Status RECRUITING

Semmelweis University Heart Center

Budapest, , Hungary

Site Status RECRUITING

Paul Stradins Clinical University hospital

Riga, , Latvia

Site Status RECRUITING

Poznan University of Medical Sciences

Poznan, , Poland

Site Status RECRUITING

Klinika Wad Wrodzonych Serca

Warsaw, , Poland

Site Status RECRUITING

Silesian Center for Heart Diseases

Zabrze, , Poland

Site Status RECRUITING

CHU de São João

Porto, , Portugal

Site Status RECRUITING

Heart Institute Nicolae Stancioiu

Cluj-Napoca, , Romania

Site Status RECRUITING

Hospital Clínico de Barcelona

Barcelona, , Spain

Site Status RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Belgium Brazil France Germany Hungary Latvia Poland Portugal Romania Spain Switzerland

Central Contacts

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Jens-Uwe Voigt, MD, PhD

Role: CONTACT

Phone: +32 16 34 90 16

Email: [email protected]

Alexis Puvrez, MD

Role: CONTACT

Phone: +32 16 34 58 43

Email: [email protected]

Facility Contacts

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Johanna Seghers

Role: primary

Nathalie Brosens

Role: backup

Edgard Prihadi, MD

Role: primary

Noa Kozmine, MSc

Role: primary

Anne-Marie Willems

Role: primary

Pieter Vervaet

Role: primary

Alexis Puvrez, MD

Role: primary

Tineke Vandeputte

Role: primary

Tessy Van Tomme

Role: primary

Renato Hortegal, MD, PhD

Role: primary

Dorothée Brzyski

Role: primary

Eleonore Serrano

Role: primary

Judith Simons

Role: primary

Doris Balling

Role: backup

Kerry Theelke, MSc

Role: primary

Caroline Morbach, MD, PhD

Role: primary

Astrid Apor, MD, PhD

Role: primary

Kaspars Kupics, MD

Role: primary

Aleksancra Cieplucha, MD

Role: primary

Karolina Plaskota, MD

Role: primary

Tomasz Kukulski, MD, PhD

Role: primary

Pedro Diogo, MD

Role: primary

Razvan Mada, MD

Role: primary

Marta Sitges, MD, PhD

Role: primary

Anne-Sophie Karnbrock

Role: primary

Other Identifiers

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S64188_v4.0

Identifier Type: -

Identifier Source: org_study_id