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Clinical Trials/NCT03667989
NCT03667989
Completed
Not Applicable

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

Tomsk National Research Medical Center of the Russian Academy of Sciences1 site in 1 country60 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Heart Failure
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
Enrollment
60
Locations
1
Primary Endpoint
CRT response
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
August 1, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

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

Outcomes

Primary Outcomes

CRT response

Time Frame: One year

ESV decreasing equal or more than 15%

Study Sites (1)

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