Improving patient selection for cardiac resynchronization therapy
Assessment of MEchaNical Dyssynchrony as Selection Criterion for Cardiac Resynchronization Therapy
This study is testing if using heart ultrasound results can help doctors choose the right patients for cardiac resynchronization therapy to improve their chances of feeling better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven Academic / other |
| Locations | 24 sites (Antwerp and 23 other locations) |
| Trial ID | NCT04225520 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to enhance the selection process for patients undergoing cardiac resynchronization therapy (CRT) by utilizing echocardiographic assessment of mechanical dyssynchrony. It compares two groups: one receiving treatment recommendations based on current clinical guidelines and another based on the mechanical properties of the left ventricle. The goal is to reduce the high non-responder rate associated with CRT, which currently stands at 30-40%. By improving patient selection, the trial seeks to ensure that only those who will benefit from CRT are treated, potentially leading to better outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with heart failure, a left ventricular ejection fraction (LVEF) of 35% or less, and specific left ventricular dimensions.
Not a fit: Patients with severe valvular disease, pulmonary hypertension unrelated to left heart disease, or those with a life expectancy of less than one year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the non-responder rate for CRT, leading to improved patient outcomes and reduced healthcare costs.
How similar studies have performed: Previous studies have indicated that using mechanical dyssynchrony assessments can significantly improve patient selection for CRT, suggesting a promising avenue for further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
(- - - - - - - - - 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
Where this trial is running
Antwerp and 23 other locations
- University Hospital Antwerp — Antwerp, Belgium (Recruiting)
- ZNA Middelheim — Antwerp, Belgium (Recruiting)
- AZ Sint-Jan Brugge — Brugge, Belgium (Recruiting)
- AZ Maria Middelares — Ghent, Belgium (Recruiting)
- Ghent University Hospital — Ghent, Belgium (Recruiting)
- UZ Leuven — Leuven, Belgium (Recruiting)
- AZ Damiaan — Ostend, Belgium (Recruiting)
- AZ Delta — Roeselare, Belgium (Recruiting)
- Dante Pazzanese Institute of Cardiology — São Paulo, Brazil (Recruiting)
- CHRU Brest — Brest, France (Recruiting)
- Groupements des hôpitaux de l'institut catholique de Lille — Lille, France (Recruiting)
- CHU Rennes - Pontchaillou Hospital — Rennes, France (Recruiting)
- St. Vinzenz-Hospital — Köln, Germany (Recruiting)
- Universitätsmedizin Rostock — Rostock, Germany (Recruiting)
- Universitätsklinikum Würzburg — Würzburg, Germany (Recruiting)
- Semmelweis University Heart Center — Budapest, Hungary (Recruiting)
- Paul Stradins Clinical University hospital — Riga, Latvia (Recruiting)
- Poznan University of Medical Sciences — Poznań, Poland (Recruiting)
- Klinika Wad Wrodzonych Serca — Warsaw, Poland (Recruiting)
- Silesian Center for Heart Diseases — Zabrze, Poland (Recruiting)
- CHU de São João — Porto, Portugal (Recruiting)
- Heart Institute Nicolae Stancioiu — Cluj-Napoca, Romania (Recruiting)
- Hospital Clínico de Barcelona — Barcelona, Spain (Recruiting)
- Universitätsspital Zürich — Zürich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Jens-Uwe Voigt, MD, PhD — Universitaire Ziekenhuizen KU Leuven
- Study coordinator: Jens-Uwe Voigt, MD, PhD
- Email: jens-uwe.voigt@uzleuven.be
- Phone: +32 16 34 90 16
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.