RecruitingNot ApplicableNCT05572957

LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB

Left Bundle Branch Pacing as Initial Therapy in Patients With Non-ischemic Heart Failure and Left Bundle Branch Block (LIT-HF Study)

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

50 participants

Start Date

Oct 14, 2022

Study Type

INTERVENTIONAL

Conditions

Heart Failure Non-ischemic Cardiomyopathy Left Bundle-Branch Block

Summary

The present study will recruit 50 symptomatic non-ischemic cardiomyopathy (NICM) patients with left ventricular ejection fraction (LVEF) below 35% and complete left bundle branch block (CLBBB), who have not received complete guideline-directed medical therapy (GDMT). Each patient was randomized to 2 groups, GDMT or left bundle branch pacing combined with GDMT (LBBP+GDMT) as initial therapy and was followed up for 2 phases: 0-6 months (phase I), 7-18 months (phase II). The primary objective is to compare the LVEF change , syncope and malignant ventricular arrhythmias between GDMT group and LBBP+GDMT group, and to observe which strategy will significantly reduce the percentage of recommendations for an implantable cardioverter-defibrillator (ICD) during phase I study. The second outcome measures including health economics, echocardiography parameters\[left ventricular ejection fraction (LVEF), left ventricular end-systolic volume (LVESV), left ventricular end-diastolic volume (LVEDV)\], N-terminal pro B-type natriuretic peptide (NT-proBNP) level, New York Heart Association (NYHA) class, 6-minute walking distance (6MWD), quality of life score(QOL) and incidence of clinical adverse events.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

Non-ischemic cardiomyopathy with LVEF≤35% as assessed by echocardiography, NYHA class II-III, and less than 3 months of optimized (complete) GDMT\*;
Sinus rhythm (paroxysmal atrial fibrillation may be present) with complete left bundle branch block meeting STRAUSS's criteria;
Between the ages of 18 and 80;
With informed consent signed.

Exclusion Criteria10

After mechanical tricuspid valve replacement;
Ischemic cardiomyopathy;
Persistent AF without AV node ablation;
History of unexplained syncope or indications for pacemaker implantation;
Indications for ICD implantation such as a history of sustained ventricular tachycardia or sudden cardiac arrest;
Unstable angina, acute MI, CABG or PCI within the past 3 months;
Enrollment in any other study；
A life expectancy of less than 12 months;
Pregnant or with child-bearing potential;
History of heart transplantation.

Interventions

DRUGGuideline-Directed Medical Therapy(GDMT)

Quadruple anti-heart failure drug therapy: BB, ACEI/ARB/ARNI, MRA, and SGLT2i. If the initial dose according to guidelines is tolerated, the protocol would then direct the uptitration of medication dose over time to a specified target dose, unless not well tolerated. \*Criteria for \<3 months of optimized (complete) GDMT: 1) according to the latest management of HF, any of the "new quadruple therapy" is not used if the condition allowed; Or 2) the dose of any drug dose not reach the maximum tolerated target; Or 3) under the maximum tolerated dose of BB, ivabradine is not added with a heart rate still ≥70 bpm at rest.

COMBINATION_PRODUCTleft bundle branch pacing combined with Guideline-Directed Medical Therapy(LBBP+GDMT)

GDMT is the same as Drug intervention. LBBP is confirmed when: 1) the LBBB morphology disappeared and the paced RBBB pattern (typical or atypical) is observed in V1; and 2) LVAT is ≤100 ms at low output(≤3 V/0.5 ms); and at least 1 of the following is achieved: a) abrupt shortening of LVAT by \>10 ms during mid/deep septal lead placement with a RBBB pattern in V1 at high output, which then remains short and constant at high and low output with further advancement of the lead to the final position; b) transition from nonselective to selective LBBP (QRS morphology transition from atypical RBBB to typical rsR' pattern in V1 and wide/large S-wave in V6 , with the appearance of an isoelectric segment and no LVAT change at high and low outputs); and c) transition from nonselective LBBP to LV septal pacing (lengthening of LVAT by at least 10 ms with or without obvious QRS morphology transition during threshold testing). HBP or BiVP is attempted using the standard-of-care technique.