Improving heart failure treatment for patients who don't respond to standard therapy

Randomized Trial of Left Bundle Branch Pacing Effect on Clinical Outcomes and Left Ventricular Remodeling in Patients With Nonresponse to Biventricular Cardiac Resynchronization Therapy

This study is testing a new heart treatment using a special device for people with heart failure who haven't felt better with standard therapies, to see if it can improve their heart function and overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences (Academic / other)
• Locations: 1 site (Tomsk)
• Trial ID: NCT05760924 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of left bundle branch pacing (LBBP) in patients with heart failure who have not responded to conventional biventricular cardiac resynchronization therapy (CRT). The study aims to enroll patients with ischemic or non-ischemic cardiomyopathy and reduced left ventricular function, focusing on those who have been symptomatic for at least three months. Participants will receive either a new CRT device or lead replacement targeting the left bundle branch to potentially enhance cardiac function and improve patient outcomes. The trial will assess clinical and echocardiographic improvements following the intervention.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 80 with symptomatic heart failure and reduced left ventricular function who are non-responders to biventricular CRT.

Not a fit: Patients who have had recent coronary interventions or acute myocardial infarction may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide significant improvements in heart function and quality of life for patients who currently have limited treatment options.

How similar studies have performed: While left bundle branch pacing is a newer technique, preliminary studies suggest it may offer benefits for patients who do not respond to traditional CRT, indicating potential for success.

Eligibility criteria

Inclusion criteria:

1. The patient is willing and able to comply with the protocol and has provided written informed consent;
2. Male or female patients aged 18 to 80 years;
3. Patients with ischemic or non-ischemic cardiomyopathy;
4. Symptomatic HF for at least 3 months prior to enrollment in the study;
5. New York Heart Association (NYHA) functional class HF ≥ II;
6. Patients who are non-responders to biventricular CRT with HF, reduced LVEF and CRT-D replacement or one of the CRT-D leads replacement indications (without LVEF increase ≥ 5% and/or without a left ventricle end-systolic volume decrease ≥ 15% after CRT-D implantation at least 1 year old);
7. Optimal HF medical therapy.

Exclusion criteria:

1. Coronary artery (CA) bypass grafting, balloon dilatation or CA stenting within 3 months prior to enrollment;
2. Acute myocardial infarction within 3 months prior to enrollment;
3. Acute coronary syndrome;
4. Patients with planned cardiovascular intervention (CA bypass grafting, balloon dilatation or CA stenting);
5. Patients listed for heart transplant;
6. Patients with implanted cardiac assist device;
7. Acute myocarditis;
8. Infiltrative myocardial disease;
9. Hypertrophic cardiomyopathy;
10. Severe primary stenosis or regurgitation of the mitral, tricuspid and aortic valves;
11. Woman currently pregnant or breastfeeding or not using reliable contraceptive measures during fertility age;
12. Mental or physical inability to participate in the study;
13. Patients unable or unwilling to cooperate within the study protocol;
14. Patients with rheumatic heart disease;
15. Mechanic tricuspid valve patients;
16. Patients with any serious medical condition that could interfere with this study;
17. Enrollment in another investigational drug or device study;
18. Patients not available for follow-up;
19. Patients with severe chronic kidney disease (estimated glomerular filtration rate ˂ 30 ml/min/1.73 m2);
20. Life expectancy ≤ 12 months;
21. Participation in another telemonitoring concept.

Where this trial is running

Tomsk

• Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences — Tomsk, Russia (Recruiting)

Study contacts

• Principal investigator: Tariel A Atabekov, Ph.D. — Cardiology Research Institute, Tomsk National Research Medical Center, Russian Academy of Sciences
• Study coordinator: Tariel A Atabekov, Ph.D.

Conditions Heart Failure; Left Bundle-Branch Block; Ischemic Cardiomyopathy; Non-ischemic Dilated Cardiomyopathy; Left Ventricular Dysfunction; Left Ventricle Remodeling; Cardiac Resynchronization Therapy; Biventricular Pacing