RecruitingPhase 2NCT07083011

A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure


Sponsor

Mayo Clinic

Enrollment

35 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is using a special type of PET scan involving a tracer called 68Ga-FAPI to look at fibroblast activity (a marker of tissue scarring and inflammation) in the hearts of people with two specific cardiac conditions — heart failure with preserved pumping function (HFpEF) and cardiac sarcoidosis (an inflammatory disease affecting the heart). Healthy volunteers are also included for comparison. **You may be eligible if...** - HFpEF group: You are 30 or older with a BMI of 30 or above, shortness of breath on exertion, normal heart pumping function (LVEF ≥50%), and a new diagnosis confirmed by specialized heart pressure measurements - Cardiac sarcoidosis group: You are 18 or older with a new, untreated diagnosis of cardiac sarcoidosis and a recent positive 18F-FDG PET scan - Healthy controls: You are 30 or older with no major chronic diseases or regular medications and a BMI below 30 **You may NOT be eligible if...** - You have active cancer, active autoimmune or inflammatory disease, severe anemia, kidney or liver disease, or are pregnant - You have a pacemaker, defibrillator, cochlear implant, or mechanical heart valve - You have a known allergy to the MRI contrast agent gadolinium - You are unable to lie flat for the scan or have claustrophobia that cannot be managed Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)

68Ga-FAPI is a gallium-68 fibroblast activation protein inhibitor that will be injected into subjects during a PET (positron emission tomography) scan


Locations(1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

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NCT07083011


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