18F-MFBG Cardiac Imaging for Heart Failure Administration

January 23, 2024 updated by: Hao Wang, Sichuan Provincial People's Hospital

18F-meta-fluorobenzylguanidine Cardiac Imaging for Evaluation of Chronic Heart Failure

The clinical feasibility of 18F-FMBG cardiac PET imaging will be observed in sympathetic nervous system activity in patients with heart failure, predicted cardiac events, guided ICD implantation, and evaluated therapy efficiency.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-center clinical study, using18F-meta-fluorobenzylguanidine (18F-MFBG) cardiac PET imaging to present the sympathetic nerve status in heart failure, including ICD implantation. Through follow-up, we analyze the correlation between the distribution of the tracer in the heart and the functions and progression of the patients, including the occurrence of ventricular arrhythmias and sudden cardiac death, And further investigate the guiding value of 18F-MFBG cardiac sympathetic nerve imaging in the screening of ICD implantation patients, including primary and secondary prevention, reducing the cost of ICD implantation and related complications. Furthermore, to evaluate the therapy efficacy for these patients with heart failure using 18F-MFBG cardiac imaging has been considered.

Study Type

Observational

Enrollment (Estimated)

100

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

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Zhi Ling Ding

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

enrolling patients with chronic heart failure with a heart function of NYHA Class II-III.

Description

Inclusion Criteria:

  • 1. Clinically confirmed patient with chronic heart failure, LVEF ≤ 40%, cardiac function NYHA 2-3 grade, survival period greater than 1 year, evaluated by the Heart Failure Center of Sichuan Provincial People's Hospital.
  • 2. Chronic heart failure patients were evaluated by the Cardiology Department of Sichuan Provincial People's Hospital 5-10 days before ICD implantation.
  • 3. All patients above have signed an informed consent form.

Exclusion Criteria:

  • 1. Heart failure, heart function NYHA levels ⅠOR Ⅳ.
  • 2. The patient has already implanted ICD or CRT.
  • 3. Heart transplant patients.
  • 4. Patients with malignant tumors.
  • 5. Heart valve disease.
  • 6. Myocardial infarction occurred within the past three months.
  • 7. The patient has contraindications for ICD implantation surgery.
  • 8. The patient does not cooperate or is unwilling to conduct the study.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
positive
positive imaging, referring to the tracer absented in the left myocardium whether diffuse or localized on 18F-FMBG cardiac imaging.
Diagnostic test: Standard medical care for heart failure
Standard treatment and care for heart failure patients from the heart failure center of Sichuan Provincial People's Hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
observe the 18F-MFBG distribution of the myocardium in heart failure patients
Time Frame: 1 year
18F-MFBG PET cardiac sympathetic nerve imaging was performed after injection of 30 minutes and 3 hours. The imaging agent distribution of left ventricular walls was observed at three axis positions (short axis, horizontal long axis, and vertical long axis). Target heart maps (17 segments) were obtained using Cedars QPS software to obtain radiation distribution counts (SMSe, SMSlate).
1 year

Collaborators and Investigators

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

Sponsor

Sichuan Provincial People's Hospital

Investigators

  • Study Director: Zhi Ling Ding, China, Sichuan Departments of Nuclear Medicine, Sichuan Provincial People's Hospita

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)

January 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

November 20, 2023

First Submitted That Met QC Criteria

November 20, 2023

First Posted (Actual)

November 28, 2023

Study Record Updates

Last Update Posted (Actual)

January 24, 2024

Last Update Submitted That Met QC Criteria

January 23, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMFBG202311

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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