LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB (NCT05572957) | Clinical Trial Compass
RecruitingNot Applicable
LBBP as Initial Therapy in Patients With Non-ischemic Heart Failure and LBBB
China50 participantsStarted 2022-10-14
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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;
What they're measuring
1
Proportion of patients requiring ICD implantation for prevention of sudden cardiac death(SCD)
Timeframe: 6-month follow-up
Trial details
NCT IDNCT05572957
SponsorThe First Affiliated Hospital with Nanjing Medical University