NCT05572957Active, not recruiting
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)
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 6 Oct 2022
- Start date
- 14 Oct 2022
- Primary completion date
- Oct 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Heart failure
- NCT number
- NCT05572957
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 14 Oct 2022 to the primary completion date, Oct 2027
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
- History of heart transplantation.
Other
- After mechanical tricuspid valve replacement;
- Ischemic cardiomyopathy;
- Persistent AF without AV node ablation;
- Enrollment in any other study；
- A life expectancy of less than 12 months;
- Pregnant or with child-bearing potential;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| West China Hospital，Sichuan University Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Unknown status |
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| The First Affiliated Hospital with Nanjing Medical University Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
| The First Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.