LBBP+GDMT
DeviceLBBP is a procedure that the pacing lead is placed at the left bundle branch to achieve electrical and mechanical synchronization by pacing the left bundle branch area with stable pacing parameters.
Other names: Early Resynchc
NCT Number: NCT06126081
This is a two-center, prospective randomized controlled trial. The aim of this study is to compare the clinical efficacy of early left bundle branch pacing for cardiac resynchronization therapy and guideline-directed medical therapy in heart failure with mild-reduced ejection fraction.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, China
Early-resync is a two-center, prospective randomized controlled trial that is designed to determine whether early left bundle branch pacing has a better impact on LV function improvement as compared with traditional guideline-directed medical therapy in heart failure with mild-reduced ejection fraction(36%≤LVEF≤50%) and complete left bundle branch block (CLBBB). Patients with symptomatic heart failure,36%≤LVEF≤50%, NYHA function class II-IV, and CLBBB(according to STRAUSS criteria) will be 1:1 randomized to LBBP+GDMT or GDMT group after enrollment and be followed at 3 and 6 months after randomization. LBBP will be performed by a double-chamber device in LBBP+GDMT group. All patients will receive GDMT. The primary endpoint is the change in the LVEF at 6 months after randomization from baseline.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
LBBP is a procedure that the pacing lead is placed at the left bundle branch to achieve electrical and mechanical synchronization by pacing the left bundle branch area with stable pacing parameters.
Other names: Early Resynchc
GDMT is defined as the drug strategy for treatment of heart failure according to the current guidelines.
Other names: Conventional treatment
Time frame: 6 months
ΔLVEF:change in LVEF in percentage (%) between baseline and 6-month follow-up
Time frame: 6 months
ΔLVEDD:change in LVEDD in millimeters between baseline and 6-month follow-up between two groups.
ΔLVESV:change in LVESV in milliliters between baseline and 6-month follow-up between two groups.
Time frame: 6 months
the percentage of patients with LVEF ≥50% at 6 month follow-up
Time frame: 6 months
NYHA function class (from I to IV) is evaluated by clinicians at each outpatient follow-up visit;
Time frame: 6 months
All-cause death: including cardiovascular and non-cardiovascular deaths. Hospitalization for heart failure: an unplanned outpatient or emergency department visit or inpatient hospitalization in which the patient presented with signs and symptoms consistent with heart failure and required medication therapy.
Time frame: 6 months
The percentage of patients with LVEF <=35% at 6 month follow-up
Time frame: 6 months
NT-proBNP in pg/ml was measured by performing a blood test;
Time frame: 6 months
6MWD in meters stands for "6-Minute Walk Distance." It is a common test used to assess a person's functional exercise capacity and cardiovascular endurance. During the test, the patient is asked to walk as far as possible within a span of 6 minutes in a straight path or designated walking course;
Time frame: 6 months
QoL stands for "Quality of Life", which is measured by The Minnesota Living with Heart Failure Questionnaire (MLHFQ). The MLHFQ is a self-administered disease-specific questionnaire for patients with HF, comprising 21 items from 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL).
Fu Wai Hospital, Beijing, China
Other
Clinical Efficacy of Early Left Bundle Branch Pacing for Cardiac Resynchronization Therapy Compared With Guideline-directed Medical Therapy in Heart Failure With Mild-reduced Ejection Fraction.
Acronym: Early-RESYNC
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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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