Evaluating heart function in patients with complete left bundle branch block
Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block
This study is trying to see how complete left bundle branch block affects heart function in patients and if certain tests can help predict who might benefit from a heart treatment called cardiac resynchronization therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Chinese Academy of Medical Sciences, Fuwai Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing) |
| Trial ID | NCT03096678 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the morphological and functional changes in patients with complete left bundle branch block (CLBBB) and to identify prognostic predictors for cardiac resynchronization therapy (CRT). Using advanced cardiovascular magnetic resonance imaging techniques, including T1 mapping and feature tracking, the study will follow patients over a 10-year period to evaluate their left ventricular function and the impact of CLBBB on heart failure outcomes. The research addresses the need for better risk stratification and candidate selection for CRT in this patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of complete left bundle branch block and in NYHA functional class I, II, or III.
Not a fit: Patients with permanent atrial fibrillation, recent myocardial infarction, or those who have undergone certain cardiac surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the selection process for cardiac resynchronization therapy, leading to better outcomes for patients with heart failure due to CLBBB.
How similar studies have performed: While the use of advanced imaging techniques in this context is still being explored, previous studies have shown promise in predicting CRT responses, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is 18 years or older and able and willing to consent. * The patient should present a complete left bundle branch block (LBBB) with QRS duration of \>120ms * The patients should be in NYHA functional class I, II or III. Exclusion Criteria: * No informed consent * Permanent atrial fibrillation, flutter or tachycardia (\>100 bpm). * Right bundle branch block * Recent myocardial infarction, within 40 days prior to enrolment. * Subject underwent coronary artery bypass graft (CABG) or valve surgery, within 90 days. * Implanted with a LV assist device (LVAD), or has reasonable probability (per investigator's discretion) of receiving a LVAD in the next year. * Severe aortic stenosis (with a valve area of \<1.0 cm2 or significant valve disease expected to be operated on within study period). * Complex and uncorrected congenital heart disease. * Claustrophobia or devices
Where this trial is running
Beijing, Beijing
- Fuwai Hospital — Beijing, Beijing, China (Recruiting)
Study contacts
- Study coordinator: Minjie Lu, MD,PhD
- Email: lumjcn@hotmail.com
- Phone: +861088398175
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.