SPECT-based Prediction and Evaluation of CRT Efficacy in CHF (MIBGinCRT)

September 29, 2020 updated by: Tomsk National Research Medical Center of the Russian Academy of Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
    • Tomsk Region
      • Tomsk, Tomsk Region, Russian Federation, 634012
        • Cardiology Research Institute, Tomsk NRMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Diagnostic test: Assessment of cardiac sympathetic innervation by 123I-MIBG
Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Investigators

  • Study Director: Sergey V Popov, MD, PhD, Tomsk NRMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Actual)

August 1, 2019

Study Completion (Actual)

August 1, 2020

Study Registration Dates

First Submitted

September 11, 2018

First Submitted That Met QC Criteria

September 11, 2018

First Posted (Actual)

September 12, 2018

Study Record Updates

Last Update Posted (Actual)

September 30, 2020

Last Update Submitted That Met QC Criteria

September 29, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIBGinCRT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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