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Enrolling by Invitation

NCT Number: NCT06149195

18F-MFBG Cardiac Imaging for Heart Failure Administration

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhi Ling Ding

Chengdu, Sichuan, 610072, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard medical care for heart failure

Diagnostic Test

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

Primary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Sichuan Provincial People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Nov 28, 2023
Registry last updated
Jan 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.