18F-MFBG Cardiac Imaging for Heart Failure Administration

• Sponsor: Sichuan Provincial People's Hospital (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT06149195
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rest Gated Myocardial Perfusion Imaging in Heart Failure	Diagnostic Test: Standard medical care for heart failure

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 Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: 18F-meta-fluorobenzylguanidine Cardiac Imaging for Evaluation of Chronic Heart Failure
• Anticipated Study Start Date: Jan 1, 2024
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2026

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. observe the 18F-MFBG distribution of the myocardium in heart failure patients [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.
• 1. Chronic heart failure patients were evaluated by the Cardiology Department of Sichuan Provincial People's Hospital 5-10 days before ICD implantation.
• 1. All patients above have signed an informed consent form.

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhi Ling Ding	Chengdu	Sichuan	China	610072

Sponsors and Collaborators

• Sichuan Provincial People's Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hao Wang, Associate senior physician, Sichuan Provincial People's Hospital
• ClinicalTrials.gov Identifier: NCT06149195
• Other Study ID Numbers: CMFBG202311
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Failure

Study Results

No Results Posted as of Nov 28, 2023