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18F-MFBG Cardiac Imaging for Heart Failure Administration

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06149195
Enrollment
100
Registered
2023-11-28
Start date
2024-01-01
Completion date
2026-12-31
Last updated
2024-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rest Gated Myocardial Perfusion Imaging in Heart Failure

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.

Interventions

DIAGNOSTIC_TESTStandard medical care for heart failure

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

Sponsors

Sichuan Provincial People's Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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. * 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.

Design outcomes

Primary

MeasureTime frameDescription
observe the 18F-MFBG distribution of the myocardium in heart failure patients1 year18F-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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026