Clinical trial NCT03096678: Prognosis of Patients With Compete Left Bundle Branch Block
Official title: Morphological and Functional Changes, Risk Stratification and Prognosis of Patients With Compete Left Bundle Branch Block
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bundle-Branch Block, Left
Cardiac Failure
ICD/Pacemaker Implantation
Cardiovascular Magnetic Resonance Imaging
Keywords: Left Bundle Branch Block
Regional/Globle cardiac function
Mechanical asynchrony
Cardiovascular Magnetic Resonance
Outcome
Cardiovascular events
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Anzhen Hospital
name: China-Japan Friendship Hospital
name: Peking Union Medical College Hospital
name: Xuanwu Hospital, Beijing
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-03-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with complete left bundle branch block

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.

Eligibility 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

Primary outcomes:
measure: All-cause death
timeFrame: 10 years
measure: Cardiovascular death
timeFrame: 10 years
measure: Heart Transplantation
timeFrame: 10 years
Secondary outcomes:
measure: ICD Implantation
timeFrame: 10 years
measure: Pacemaker Implantation
timeFrame: 10 years
measure: Myocardial Infarction
timeFrame: 10 years
measure: Hospitalization due to heart failure
timeFrame: 10 years
measure: Stroke
timeFrame: 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
Study officials:
affiliation: Fuwai Hospital, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical, Sciences and Peking Union Medical College
name: Minjie Lu, MD,PhD
role: STUDY_CHAIR
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