SPECT-based Prediction and Evaluation of CRT Efficacy in CHF

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single-photon Emission Computed Tomography for Prediction and Evaluation of Cardiac Resynchronization Therapy Efficacy in Chronic Heart Failure Patients

Conditions
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Chronic Heart Failure

Intervention / Treatment
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* Diagnostic Test: Assessment of cardiac sympathetic innervation by 123I-MIBG


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 123I-MIBG CZT SPECT<br>Patients with ischemic and non-ischemic heart failure with indications for CRT. Assessment of cardiac sympathetic innervation by 123IMIBG CZT SPECT. | Diagnostic Test: Assessment of cardiac sympathetic innervation by 123I-MIBG<br>* Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRT response | ESV decreasing equal or more than 15% | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SPECT, 123I-MIBG, Chronic heart failure, Cardiac resynchronization therapy, CZT