Assessment of Cardiac Fibrosis in HCM Using FAPI-PET/MR

Assessment of Cardiac Fibrosis in Hypertrophic Cardiomyopathy Using 68Ga-FAPI-46 PET/MR - PET: Positron Emission Tomography MR: Magnetic resonance imaging

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs051240167

Enrollment

Registered

2024-10-25

Start date

2024-12-03

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Hypertrophic Cardiomyopathy Hypertrophic Cardiomyopathy, Cardiac Fibrosis

Interventions

Perform 68Ga-FAPI PET/MR, contrast-enhanced MRI examinations, and blood sampling.

FAPI-PET

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosed with HCM by a cardiologist, the patient has been enrolled in the "Prospective Registry for Evaluating the Clinical Diagnosis of Hypertrophic Cardiomyopathy (PREVAIL-HCM)" clinical trial, led by Kyoto University. 2) Performed cardiac MRI in Kyoto University Hospital

Exclusion criteria

Exclusion criteria: Pregnant or possibly pregnant. Extremely poor general condition (vital sign abnormalities, systolic blood pressure below 90 mmHg, heart rate over 100, etc.) or significant communication impairment. Contraindications to FAPI-PET/MR or gadolinium-enhanced cardiac MRI. (History of allergy to the administered agent, eGFR less than 30 ml/min/1.73 m2) Other patients deemed unsuitable as study subjects by the principal investigator, the responsible investigator, or the co-investigator.

Design outcomes

Primary

Measure	Time frame
For the total cardiac fibrosis burden in patients with HCM, evaluate the correlation between the amount of fibrosis expressed by FAPI-PET (product of SUVmean and region of interest) in the myocardium as calculated by contrast enhanced cardiac MRI.	—

Secondary

Measure	Time frame
To compare the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI between severe HCM patients and regular HCM patients, and evaluate the extent of fibrosis or damage indicated by each technique. To assess the correlation between the polygenic score and the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI in HCM patients (both severe and regular). To evaluate the relationship between risk score for sudden cardiac death score and the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI between the severe HCM group and the regular HCM group.	—

Measure

Time frame

To compare the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI between severe HCM patients and regular HCM patients, and evaluate the extent of fibrosis or damage indicated by each technique. To assess the correlation between the polygenic score and the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI in HCM patients (both severe and regular). To evaluate the relationship between risk score for sudden cardiac death score and the imaging results of FAPI-PET/MR and conventional contrast enhanced cardiac MRI between the severe HCM group and the regular HCM group.

—

Contacts

Public ContactReo Hata

Center of iPS Cell Research and Application (CiRA), Kyoto University.

leohata043@kuhp.kyoto-u.ac.jp+81-75-366-7371

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026