Pilot Study of 68Ga-FAPI PET Scan to Evaluate Heart Failure with Preserved Ejection Fraction and Cardiac Sarcoidosis

What this Trial Is About

Researchers are evaluating the performance of a diagnostic imaging agent called 68Ga-FAPI gallium-68-labeled fibroblast activation protein inhibitor in people with heart failure with preserved ejection fraction HFpEF. This Phase 2 study aims to understand how well 68Ga-FAPI PET scans can detect and measure heart tissue changes in patients with HFpEF, including those who are obese and those with active cardiac sarcoidosis, compared to healthy individuals. Participants will receive an injection of 68Ga-FAPI during a PET positron emission tomography scan to visualize areas of fibroblast activation in the heart. The study includes three groups obese subjects with HFpEF, patients with active cardiac sarcoidosis, and healthy volunteers. The imaging and measurements will be taken at baseline and again after 6 months to assess myocardial volume, uptake area, uptake intensity, and target-to-background ratio of 68Ga-FAPI. Throughout the study, participants will undergo PETCT and cardiac magnetic resonance CMR scans while lying in a supine position. Researchers will evaluate standardized uptake values and other imaging parameters at the start and six months later. The total study duration extends to July 2027, during which participants heart function and tissue characteristics are closely monitored to assess the diagnostic potential of the imaging agent.

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