Left Ventricular DyssynchronyAMEND-CRTNCT04225520
AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT
A study testing Cardiac resynchronization therapy ON and Cardiac resynchronization therapy OFF in people with Left Ventricular Dyssynchrony and Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 24 sites in 11 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated
- What is being tested?
- Cardiac resynchronization therapy ON and Cardiac resynchronization therapy OFF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 24 sitesin 11 countries
- Study dates
- 10 Dec 2020to 1 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
(- - - - - - - - - Inclusion Criteria - - - - - - - - -)
The proposed inclusion criteria represent the minimum recommendations for CRT implantation in heart failure patients according to the ESC 2021 guidelines. In addition:
- 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
Trial locations and contacts
24 sites in 11 countries.
24 sites in 11 countries
Belgium8 sites
University Hospital Antwerp
Antwerp, 2000
ZNA Middelheim
Antwerp, 2020
AZ Sint-Jan Brugge
Bruges, 8000
AZ Maria Middelares
Ghent, 9000
Ghent University Hospital
Ghent, 9000
UZ Leuven
Leuven, 3000
AZ Damiaan
Ostend, 8400
AZ Delta
Roeselare, 8800
France3 sites
CHRU Brest
Brest, 29200
Groupements des hôpitaux de l'institut catholique de Lille
Lille, 59800 Lille
CHU Rennes - Pontchaillou Hospital
Rennes, 35000
Germany3 sites
St. Vinzenz-Hospital
Cologne, 50733
Universitätsmedizin Rostock
Rostock, 18057
Universitätsklinikum Würzburg
Würzburg, 97080
Poland3 sites
Poznan University of Medical Sciences
Poznan, 61-701
Klinika Wad Wrodzonych Serca
Warsaw, 04-628
Silesian Center for Heart Diseases
Zabrze, 41-800
About this study
Official title: Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy
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.
- Conditions
- Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated, Cardiac Remodeling, Ventricular
- Being tested
- Cardiac resynchronization therapy ON, Cardiac resynchronization therapy OFF
- Keywords
- Cardiac resynchronization therapy, Heart failure, Mechanical dyssynchrony, Echocardiography, Apical rocking, Septal flash, Left ventricle
- Medical subject headings
- Heart Failure, Cardiomyopathy, Dilated, Ventricular Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac resynchronization therapy ONDevice
Implantation of a CRT device. Bi-ventricular pacing will be turned ON.
Cardiac resynchronization therapy OFFDevice
Implantation of a CRT device. Bi-ventricular pacing will be turned OFF.
| Study group | Role | What they receive |
|---|---|---|
| Treatment recommendation based on guidelines | Active comparator | 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. Receives: Device: Cardiac resynchronization therapy ON |
| Treatment recommendation based on mechanical dyssynchrony | Experimental | 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. Receives: Device: Cardiac resynchronization therapy ON; Device: Cardiac resynchronization therapy OFF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume response and Packer Clinical Composite Score
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.
Measured: 12 months follow-up
Secondary outcomes (6)
Effect on left ventricular function in both arms
- ≥ 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
Measured: 12 months follow-up
Difference in quality of life as measured by the Minnesota Living with Heart Failure questionnaire score and EuroQol 5D index score in both arms
- ≥ 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
Measured: 12 months follow-up
Difference in 6 minute walk test distance in both arms
≥ 45 meters difference in change from baseline to month 12
Measured: 12 months follow-up
Difference in predictive value for volume response
≥15% relative reduction in left ventricular end-systolic volume from baseline to month 12 will be considered as a response
Measured: 12 months follow-up
Difference in predictive value for long-term patient outcome in both arms
Cox's proportional hazards model:
- At 1 year for 'worsened' PCCS
- At 3 and 5 years for cardiovascular mortality and heart failure hospitalization
Measured: 1 year, 3 years and 5 years follow-up
Difference in long-term patient outcome in both arms
- 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
Measured: 3 years and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start10 Dec 2020
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Left Ventricular DyssynchronyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jens-Uwe Voigt, MD, PhD, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Jens-Uwe Voigt, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225520
- Sponsor's protocol ID
- S64188_v5.0
- Acronym
- AMEND-CRT
- Status last verified
- Apr 2026
- First submitted
- 8 Jan 2020
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Available upon reasonable request after acceptance of publications.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy
- ClinicalTrials.gov ID
- NCT04225520
- Acronym / sponsor ID
- AMEND-CRT / S64188_v5.0
- Conditions
- Left Ventricular Dyssynchrony, Heart Failure, Cardiomyopathy, Dilated, Cardiac Remodeling, Ventricular
- Keywords
- Cardiac resynchronization therapy, Heart failure, Mechanical dyssynchrony, Echocardiography, Apical rocking, Septal flash, Left ventricle
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 10 Dec 2020 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment recommendation based on guidelines | Active comparator | Device: Cardiac resynchronization therapy ONTreatment 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. |
| Treatment recommendation based on mechanical dyssynchrony | Experimental | Device: Cardiac resynchronization therapy ON, Device: Cardiac resynchronization therapy OFFTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac resynchronization therapy ONImplantation of a CRT device. Bi-ventricular pacing will be turned ON. | Device | Treatment recommendation based on guidelines, Treatment recommendation based on mechanical dyssynchrony |
| Cardiac resynchronization therapy OFFImplantation of a CRT device. Bi-ventricular pacing will be turned OFF. | Device | Treatment recommendation based on mechanical dyssynchrony |
Primary outcome
Volume response and Packer Clinical Composite Score
Time frame: 12 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.
6 secondary outcomes
Effect on left ventricular function in both arms
Time frame: 12 months follow-up
Difference in quality of life as measured by the Minnesota Living with Heart Failure questionnaire score and EuroQol 5D index score in both arms
Time frame: 12 months follow-up
Difference in 6 minute walk test distance in both arms
Time frame: 12 months follow-up
Difference in predictive value for volume response
Time frame: 12 months follow-up
Difference in predictive value for long-term patient outcome in both arms
Time frame: 1 year, 3 years and 5 years follow-up
Difference in long-term patient outcome in both arms
Time frame: 3 years and 5 years follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. Available upon reasonable request after acceptance of publications.
Related trials for Left Ventricular Dyssynchrony
Recruiting
PReventive Effect Of Left Bundle Branch Area Pacing Versus righT vEntricular paCing on All Cause deaTh, Heart Failure Progression, and Ventricular dysSYNChrony in Patients With Substantial Ventricular Pacing (PROTECT-SYNC): Multicenter Prospective Randomized Controlled Trial
Bradyarrhythmia, Atrioventricular Block
Recruiting
Conventional Biventricular Versus Left Bundle Branch Pacing on Outcomes in Heart Failure Patients
Heart Failure, Left Bundle-Branch Block
Enrolling by invitationObservational study
COR-INSIGHT: Optimizing Cardiovascular and Cardiopulmonary Outcomes with AI-Driven Multiplexed Indications Using COR ECG Wearable
Cardiopulmonary Failure, Myocardial Infarction (MI)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens-Uwe Voigt, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
24 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac resynchronization therapy ON and Cardiac resynchronization therapy OFF in people with Left Ventricular Dyssynchrony and Heart Failure, run by Universitaire Ziekenhuizen KU Leuven at 24 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Belgium, France, Germany, Poland, Brazil and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume response and Packer Clinical Composite Score (time frame: 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.