SPECT-based Prediction and Evaluation of CRT Efficacy in CHF

NCT ID: NCT03667989

Last Updated: 2020-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2020-08-01

Brief Summary

This study evaluates the state of the cardiac sympathetic activity and the severity of ventricular dyssynchrony in chronic heart failure patients and assesses the capabilities of radionuclide indication methods in determining the prognosis and evaluating the results of cardiac resynchronization therapy in chronic heart failure patients.

Detailed Description

In heart failure, abnormal activation of cardiac sympathetic system has been shown to be of pathophysiological significance. However, the left ventricular (LV) dyssynchrony has a detrimental effect on LV systolic and diastolic functions in heart failure patients. The effects of LV dyssynchrony on cardiac sympathetic activity are not yet fully understood. Dilated cardiomyopathy is a common cause of severe chronic heart failure. Cardiac resynchronization therapy (CRT) is a disease modifying device-driven treatment that can reduce morbidity and mortality in patients with heart failure. However, this type of treatment does not lead to the expected results in 25% to 30% of patients despite the successful implantation of a CRT device. In addition, CRT is associated with high cost and potential morbidity. Therefore, the search for new highly informative criteria for selecting patients for this type of treatment remains a relevant task of modern medicine. It is expected that the results obtained will complement and expand current state of knowledge regarding the relationships between cardiac remodeling processes and the state of cardiac sympathetic activity. In addition, obtained data will allow to predict LV remodeling dynamics after the correction of contractile dysfunction of the heart.

Conditions

Chronic Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

123I-MIBG CZT SPECT

Patients with ischemic and non-ischemic heart failure with indications for CRT. Assessment of cardiac sympathetic innervation by 123IMIBG CZT SPECT.

Group Type: OTHER

Assessment of cardiac sympathetic innervation by 123I-MIBG

Intervention Type: DIAGNOSTIC_TEST

Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT

Interventions

Assessment of cardiac sympathetic innervation by 123I-MIBG

Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Chronic heart failure NYHA III and IV class
• LVEF ≤ 35 %
• QRS ≥ 150 ms on ECG
• The presence of LBBB on ECG
• Sinus rhythm
• Optimal pharmacological treatment of heart failure

Exclusion Criteria

• Contraindications to SPECT due to hypersensitivity to radiopharmacuticals such as 2-methoxy-isobutyl-isonitrile-(99mTc) and (123)I-Meta-iodobenzylguanidine or any of the excipients
• Pregnancy
• Breastfeeding
• Refusal to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomsk National Research Medical Center of the Russian Academy of Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey V Popov, MD, PhD

Role: STUDY_DIRECTOR

Tomsk NRMC

Locations

Cardiology Research Institute, Tomsk NRMC

Tomsk, Tomsk Oblast, Russia

Countries

Russia

References

Atabekov T, Korepanov V, Krivolapov S, Khlynin M, Afanasiev S, Golubenko M, Batalov R, Popov S. Mitochondrial DNA Polymorphisms of Peripheral Blood Mononuclear Cells Associated with Sustained Ventricular Tachycardia in Patients with Cardioverter-Defibrillator Implantation Indications. Rev Cardiovasc Med. 2025 Mar 17;26(3):26744. doi: 10.31083/RCM26744. eCollection 2025 Mar.

Reference Type: DERIVED

PMID: 40160580 (View on PubMed)

Other Identifiers

MIBGinCRT

Identifier Type: -

Identifier Source: org_study_id