Heart Failure Clinical Trial
— LIT-HFOfficial title:
Left Bundle Branch Pacing as Initial Therapy in Patients With Non-ischemic Heart Failure and Left Bundle Branch Block (LIT-HF Study)
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 | Recruiting |
Enrollment | 50 |
Est. completion date | June 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Non-ischemic cardiomyopathy with LVEF=35% as assessed by echocardiography, NYHA class II-III, and less than 3 months of optimized (complete) GDMT*; 2. Sinus rhythm (paroxysmal atrial fibrillation may be present) with complete left bundle branch block meeting STRAUSS's criteria; 3. Between the ages of 18 and 80; 4. With informed consent signed. Exclusion Criteria: 1. After mechanical tricuspid valve replacement; 2. Ischemic cardiomyopathy; 3. Persistent AF without AV node ablation; 4. History of unexplained syncope or indications for pacemaker implantation; 5. Indications for ICD implantation such as a history of sustained ventricular tachycardia or sudden cardiac arrest; 6. Unstable angina, acute MI, CABG or PCI within the past 3 months; 7. Enrollment in any other study; 8. A life expectancy of less than 12 months; 9. Pregnant or with child-bearing potential; 10. History of heart transplantation. |
Country | Name | City | State |
---|---|---|---|
China | Fuwai Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing |
China | West China Hospital, Sichuan University | Chengdu | Sichuan |
China | The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
China | Fujian Medical University Union Hospital | Fuzhou | Fujian |
China | The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu |
China | The First Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital with Nanjing Medical University | Chinese Academy of Medical Sciences, Fuwai Hospital, First Affiliated Hospital of Wenzhou Medical University, Fujian Medical University Union Hospital, The First Affiliated Hospital of Dalian Medical University, West China Hospital |
China,
Heidenreich PA, Bozkurt B, Aguilar D, Allen LA, Byun JJ, Colvin MM, Deswal A, Drazner MH, Dunlay SM, Evers LR, Fang JC, Fedson SE, Fonarow GC, Hayek SS, Hernandez AF, Khazanie P, Kittleson MM, Lee CS, Link MS, Milano CA, Nnacheta LC, Sandhu AT, Stevenson LW, Vardeny O, Vest AR, Yancy CW. 2022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2022 May 3;145(18):e895-e1032. doi: 10.1161/CIR.0000000000001063. Epub 2022 Apr 1. Erratum In: Circulation. 2022 May 3;145(18):e1033. Circulation. 2022 Sep 27;146(13):e185. Circulation. 2023 Apr 4;147(14):e674. — View Citation
Huang W, Su L, Wu S, Xu L, Xiao F, Zhou X, Ellenbogen KA. A Novel Pacing Strategy With Low and Stable Output: Pacing the Left Bundle Branch Immediately Beyond the Conduction Block. Can J Cardiol. 2017 Dec;33(12):1736.e1-1736.e3. doi: 10.1016/j.cjca.2017.09.013. Epub 2017 Sep 22. — View Citation
McDonagh TA, Metra M, Adamo M, Gardner RS, Baumbach A, Bohm M, Burri H, Butler J, Celutkiene J, Chioncel O, Cleland JGF, Coats AJS, Crespo-Leiro MG, Farmakis D, Gilard M, Heymans S, Hoes AW, Jaarsma T, Jankowska EA, Lainscak M, Lam CSP, Lyon AR, McMurray JJV, Mebazaa A, Mindham R, Muneretto C, Francesco Piepoli M, Price S, Rosano GMC, Ruschitzka F, Kathrine Skibelund A; ESC Scientific Document Group. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Eur Heart J. 2021 Sep 21;42(36):3599-3726. doi: 10.1093/eurheartj/ehab368. No abstract available. Erratum In: Eur Heart J. 2021 Oct 14;: — View Citation
Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, Saleem M, Mandrola J, Genovese D, Oren JW, Subzposh FA, Aziz Z, Beaser A, Shatz D, Besser S, Lang RM, Trohman RG, Knight BP, Tung R; His-SYNC Investigators. On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial. Heart Rhythm. 2019 Dec;16(12):1797-1807. doi: 10.1016/j.hrthm.2019.05.009. Epub 2019 May 13. — View Citation
Wang Y, Zhu H, Hou X, Wang Z, Zou F, Qian Z, Wei Y, Wang X, Zhang L, Li X, Liu Z, Xue S, Qin C, Zeng J, Li H, Wu H, Ma H, Ellenbogen KA, Gold MR, Fan X, Zou J; LBBP-RESYNC Investigators. Randomized Trial of Left Bundle Branch vs Biventricular Pacing for Cardiac Resynchronization Therapy. J Am Coll Cardiol. 2022 Sep 27;80(13):1205-1216. doi: 10.1016/j.jacc.2022.07.019. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients requiring ICD implantation for prevention of sudden cardiac death(SCD) | After treatment with two strategies(GDMT, LBBP+GDMT), the percentages of LVEF still =35% and/or ventricular arrhythmia events was assessed in both groups. That is, the percentage of patients who are eligible for primary/secondary prevention ICD implantation. | 6-month follow-up | |
Secondary | Health economics | The cost of the two treatment strategies were evaluated comprehensively, including each inpatient, outpatient and unplanned follow-up | 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Changes in LVEF | LVEF is assessed by echocardiography (Simpson's rule) and compared between the baseline and follow-up. | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Changes in LVESV | LVESV is assessed by echocardiography (Simpson's rule) and compared between the baseline and follow-up. | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Changes in LVEDV | LVEDV is assessed by echocardiography (Simpson's rule) and compared between the baseline and follow-up. | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Changes in concentration of NT-proBNP in blood between baseline and follow-up | Blood test is performed at each time frame to determine the concentration of NT-proBNP(unit: pg/mL) | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Changes in New York Heart Association Heart Function Classification between baseline and follow-up | The higher the classification, the more severe the heart failure symptoms(four levels: I, II, III and IV) | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Change in Quality Of Life Questionnaire score between baseline and follow-up | Reflect the effect of heart failure on quality of life, and higher scores represent a worse outcome | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up | |
Secondary | Incidence of clinical adverse events | Including date and number of all-cause mortality, heart failure hospitalization, cardiovascular hospitalization and malignant ventricular arrhythmia | Baseline; 3-month, 6-month, 12-month, and 18-month follow-up |
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