SPECT-based Prediction and Evaluation of CRT Efficacy in CHF (MIBGinCRT)
Primary Purpose
Chronic Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Assessment of cardiac sympathetic innervation by 123I-MIBG
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Heart Failure focused on measuring SPECT, 123I-MIBG, Chronic heart failure, Cardiac resynchronization therapy, CZT
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
Sites / Locations
- Cardiology Research Institute, Tomsk NRMC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
123I-MIBG CZT SPECT
Arm Description
Patients with ischemic and non-ischemic heart failure with indications for CRT. Assessment of cardiac sympathetic innervation by 123IMIBG CZT SPECT.
Outcomes
Primary Outcome Measures
CRT response
ESV decreasing equal or more than 15%
Secondary Outcome Measures
Full Information
NCT ID
NCT03667989
First Posted
September 11, 2018
Last Updated
September 29, 2020
Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03667989
Brief Title
SPECT-based Prediction and Evaluation of CRT Efficacy in CHF
Acronym
MIBGinCRT
Official Title
Single-photon Emission Computed Tomography for Prediction and Evaluation of Cardiac Resynchronization Therapy Efficacy in Chronic Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
August 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tomsk National Research Medical Center of the Russian Academy of Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Heart Failure
Keywords
SPECT, 123I-MIBG, Chronic heart failure, Cardiac resynchronization therapy, CZT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
123I-MIBG CZT SPECT
Arm Type
Other
Arm Description
Patients with ischemic and non-ischemic heart failure with indications for CRT. Assessment of cardiac sympathetic innervation by 123IMIBG CZT SPECT.
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of cardiac sympathetic innervation by 123I-MIBG
Intervention Description
Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT
Primary Outcome Measure Information:
Title
CRT response
Description
ESV decreasing equal or more than 15%
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergey V Popov, MD, PhD
Organizational Affiliation
Tomsk NRMC
Official's Role
Study Director
Facility Information:
Facility Name
Cardiology Research Institute, Tomsk NRMC
City
Tomsk
State/Province
Tomsk Region
ZIP/Postal Code
634012
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
SPECT-based Prediction and Evaluation of CRT Efficacy in CHF
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