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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: kgma1011@mail.ru
• Phone: +79528002625

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing Biventricular Pacing and Left Bundle Branch Pacing for Heart Failure

  This study is testing whether a new way of pacing the heart can help people with heart failure feel better and improve their heart function compared to the standard method.

  Recruiting Tomsk National Research Medical Center of the Russian Academy of Sciences · Tomsk · NCT05769036

• Left bundle branch area pacing with multimodal guidance vs. conventional pacing for heart failure with complete left bundle branch block

  A multicenter trial tests whether using multimodal data to guide left bundle branch area pacing helps people with heart failure and complete left bundle branch block, compared with traditional biventricular pacing.

  Recruiting Second Affiliated Hospital of Nanchang University · Nanchang, Jiangxi · NCT07814612

• PET imaging with XTR003 and 18F-FDG to find recoverable heart muscle in ischemic cardiomyopathy

  This trial tests whether adding XTR003 injection to 18F‑FDG PET scans helps identify living heart muscle in adults (18–85) with ischemic cardiomyopathy who are candidates for complete revascularization.

  Recruiting Phase 2 Sinotau Pharmaceutical Group · Beijing, Beijing Municipality and 2 other locations · NCT07443696

• 18F-mFBG imaging to map heart nerve signals in people with ischemic heart failure and ICDs

  Researchers are testing whether 18F-mFBG PET imaging can see heart nerve activity in people with ischemic heart failure and an ICD.

  Recruiting Phase 2 Innervate Radiopharmaceuticals LLC (Formerly: Illumina Radiopharmaceuticals LLC) · Houston, Texas · NCT06965621

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Using radiotherapy to treat advanced heart failure

  This study is testing if a single low dose of radiation therapy can help people with advanced heart failure feel better and improve their heart function.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT06661876

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.