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Prognosis of Patients With Compete Left Bundle Branch Block

Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03096678
Enrollment
500
Registered
2017-03-30
Start date
2010-01-01
Completion date
2025-12-31
Last updated
2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bundle-Branch Block, Left, Cardiac Failure, Cardiovascular Magnetic Resonance Imaging, ICD/Pacemaker Implantation

Keywords

Left Bundle Branch Block, Regional/Globle cardiac function, Mechanical asynchrony, Cardiovascular Magnetic Resonance, Outcome, Cardiovascular events

Brief summary

The investigators sought to evaluate the morphological and functional changes, risk stratification and prognosis of patients of participants with compete left bundle branch block (CLBBB). The conduction of this study was largely due to the increased clinical requirement, which reflected the increased awareness among physicians of heart failure due to asynchronous cardiac function caused by CLBBB. The investigators also aim to figure out the time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

Detailed description

The effect of cardiac resynchronization therapy (CRT) for heart failure patients was heterogeneous. Candidate selection was important before intervention. The underlying mechanical dyssynchrony of left ventricular bundle branch block was insufficiently descripted. Earlier study of investigators found novel imaging methods such as cardiovascular magnetic resonance imaging including T1 Mapping and feature tracking imaging can provide more detailed information about regional and global LV function in patients. While the role of new cardiac MR imaging techniques in predicting CRT responses, especially in LBBB patients, is still insufficient. Z Chen et al used T1 mapping technique to quantitatively assess the diffuse fibrosis burden of myocardial in heart failure patients. But they found focal fibrosis burden, not diffuse burden, is associated with a poor response to CRT. Other cardiac MR imaging parameters also showed potential predictors of CRT, such as 16 segment time-to-maximum radial wall thickness , scar locations and RV septal lead placement.In this study cardiovascular magnetic resonance imaging (including T1 Mapping combined with feature tracking imaging ) will be applied to follow up LV function in LBBB patients (with or without intervention) in 10 years to find out prognostic predictors and time point or CMR parameters for cardiac resynchronization therapy in patients with CLBBB.

Interventions

DIAGNOSTIC_TESTCardiac Magnetic Resonance Imaging

Using a comprehensive MR study (Function, LGE, Tissue Characterization, Strain, T1/T2 mapping) to predict the outcome of LBBB with different cardiac function.

Sponsors

Beijing Anzhen Hospital
CollaboratorOTHER
China-Japan Friendship Hospital
CollaboratorOTHER
Peking Union Medical College Hospital
CollaboratorOTHER
Xuanwu Hospital, Beijing
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Chinese Academy of Medical Sciences, Fuwai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years

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

Design outcomes

Primary

MeasureTime frame
All-cause death10 years
Cardiovascular death10 years
Heart Transplantation10 years

Secondary

MeasureTime frame
Hospitalization due to heart failure10 years
ICD Implantation10 years
Stroke10 years
Pacemaker Implantation10 years
Myocardial Infarction10 years

Countries

China

Contacts

Primary ContactMinjie Lu, MD,PhD
lumjcn@hotmail.com+861088398175
Backup ContactJinhui Li, MD
ljhasuka@163.com+861088398158

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026