18F-MFBG Cardiac Imaging for Heart Failure Administration

NCT ID: NCT06149195

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Rest Gated Myocardial Perfusion Imaging in Heart Failure

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

positive

positive imaging, referring to the tracer absented in the left myocardium whether diffuse or localized on 18F-FMBG cardiac imaging.

Standard medical care for heart failure

Intervention Type: DIAGNOSTIC_TEST

Standard treatment and care for heart failure patients from the heart failure center of Sichuan Provincial People's Hospital.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sichuan Provincial People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Wang

Associate senior physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zhi Ling Ding

Role: STUDY_DIRECTOR

China, Sichuan Departments of Nuclear Medicine, Sichuan Provincial People's Hospita

Locations

Zhi Ling Ding

Chengdu, Sichuan, China

Countries

China

Other Identifiers

CMFBG202311

Identifier Type: -

Identifier Source: org_study_id