SPECT-based Prediction and Evaluation of CRT Efficacy in CHF

Chronic Heart Failure Clinical Trial

— MIBGinCRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03667989
• Other study ID #: MIBGinCRT
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 1, 2020

Study information

• Verified date: September 2019
• Source: Tomsk National Research Medical Center of the Russian Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 1, 2020
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Diagnostic Test:
• Assessment of cardiac sympathetic innervation by 123I-MIBG
Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT

Locations

Country	Name	City	State
Russian Federation	Cardiology Research Institute, Tomsk NRMC	Tomsk	Tomsk Region

Sponsors (1)

Lead Sponsor	Collaborator
Tomsk National Research Medical Center of the Russian Academy of Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CRT response	ESV decreasing equal or more than 15%	One year