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NCT Number: NCT04225520

AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Left Ventricular Dyssynchrony Cardiac Remodeling, Ventricular Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Ventricular Remodeling

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Antwerp, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

(- - - - - - - - - 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

Treatment and study plan

Cardiac resynchronization therapy ON

Device

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

Cardiac resynchronization therapy OFF

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Effect on left ventricular function in both arms

    Time frame: 12 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

  2. 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

    • ≥ 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

  3. Difference in 6 minute walk test distance in both arms

    Time frame: 12 months follow-up

    ≥ 45 meters difference in change from baseline to month 12

  4. Difference in predictive value for volume response

    Time frame: 12 months follow-up

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

  5. Difference in predictive value for long-term patient outcome in both arms

    Time frame: 1 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

  6. Difference in long-term patient outcome in both arms

    Time frame: 3 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy

Acronym: AMEND-CRT

Important dates

Study start
2020
Primary completion
2027
Study completion
2030
First posted
Jan 13, 2020
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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