SPECT-based Prediction and Evaluation of CRT Efficacy in CHF

Not Applicable

Completed

• Conditions: Chronic Heart Failure
• Interventions: Diagnostic Test: Assessment of cardiac sympathetic innervation by 123I-MIBG

• Registration Number: NCT03667989
• Lead Sponsor: Tomsk National Research Medical Center of the Russian Academy of Sciences

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2018-09-11
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Primary Completion: 2019-08-01
• Status Verified: 2019-09
• Study Completion: 2020-08-01
• Last Update Submitted: 2020-09-29
• Last Update Posted: 2020-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
CRT response	One year	ESV decreasing equal or more than 15%

Trial Locations

Locations (1)

Cardiology Research Institute, Tomsk NRMC; 🇷🇺 Tomsk, Tomsk Region, Russian Federation