NCT03667989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 11, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

September 30, 2020

Status Verified

September 1, 2019

Enrollment Period

1.9 years

First QC Date

September 11, 2018

Last Update Submit

September 29, 2020

Conditions

Keywords

SPECT123I-MIBGChronic heart failureCardiac resynchronization therapyCZT

Outcome Measures

Primary Outcomes (1)

  • CRT response

    ESV decreasing equal or more than 15%

    One year

Study Arms (1)

123I-MIBG CZT SPECT

OTHER

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

Interventions

Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT

123I-MIBG CZT SPECT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Research Institute, Tomsk NRMC

Tomsk, Tomsk Oblast, 634012, Russia

Location

Related Publications (1)

  • Atabekov T, Korepanov V, Krivolapov S, Khlynin M, Afanasiev S, Golubenko M, Batalov R, Popov S. Mitochondrial DNA Polymorphisms of Peripheral Blood Mononuclear Cells Associated with Sustained Ventricular Tachycardia in Patients with Cardioverter-Defibrillator Implantation Indications. Rev Cardiovasc Med. 2025 Mar 17;26(3):26744. doi: 10.31083/RCM26744. eCollection 2025 Mar.

Study Officials

  • Sergey V Popov, MD, PhD

    Tomsk NRMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2018

First Posted

September 12, 2018

Study Start

September 1, 2017

Primary Completion

August 1, 2019

Study Completion

August 1, 2020

Last Updated

September 30, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations