Evaluating Cardiac Fibrosis in Heart Failure Using 68Ga-FAPI PETCT Compared to MRI A Pilot Study in Patients with HFrEF and HFpEF

What this Trial Is About

Researchers are investigating myocardial fibrosis in patients with heart failure, focusing on those with non-ischemic dilated cardiomyopathy HFrEF phenotype and hypertrophic cardiomyopathy a subtype of HFpEF. The study explores the use of gallium-68-labeled fibroblast activation protein inhibitor positron emission tomographycomputed tomography 68Ga-FAPI PETCT compared to the current standard, cardiac magnetic resonance imaging CMR, to better detect and monitor fibrosis activity. This observational pilot study aims to improve non-invasive methods for assessing fibrogenesis and treatment effects. Participants will undergo 68Ga-FAPI PETCT scans to evaluate myocardial fibrosis. The study includes patients with preserved or reduced left ventricular ejection fraction meeting specific imaging and diagnostic criteria. Recent echocardiograms, cardiac magnetic resonance imaging, and normal coronary angiogram or CT coronary angiography are required within specified timelines. The study is single-center and prospective, focusing on developing new assessment methodologies for future anti-fibrotic therapies. During the study, participants will be monitored through imaging assessments at baseline and after two years to measure 68Ga-FAPI uptake. Researchers will also correlate imaging findings with serum cardiac biomarkers and cardiovascular events. The study requires participants to have stable conditions without recent hospitalizations for heart failure and includes safety monitoring concerning kidney function and tolerance to procedures. The total participation duration may span over two years with repeated evaluations.

⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure