NCT07296081

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

Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: University of Coimbra · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Heart failure (HF) is a clinical syndrome with increasing incidence and prevalence, associated with high morbidity, mortality, and economic impact, despite therapeutic advances. Myocardial fibrosis is a common feature across different pathophysiological processes and plays a key role in HF development, with growing research interest specifically in non-ischemic dilated cardiomyopathy (HFrEF phenotype) and hypertrophic cardiomyopathy (HFpEF phenotype). Given its potential reversibility with certain drugs, fibrosis is an attractive therapeutic target, requiring non-invasive methods to monitor fibrogenesis and treatment efficacy. Cardiac magnetic resonance imaging (CMR) is the gold standard for detecting fibrosis but cannot distinguish between active and inactive fibrosis or detect early stages, limitations that may be addressed by gallium-68-labeled fibroblast activation protein inhibitor positron emission tomography/computed tomography (68Ga-FAPI PET/CT). This single-center, prospective, observational pilot study aims primarily to assess myocardial fibrosis in patients with HFrEF (non-ischemic dilated cardiomyopathy) and a subtype of HFpEF (hypertrophic cardiomyopathy) using 68Ga-FAPI PET/CT compared to CMR. Secondary objectives include developing 68Ga-FAPI uptake assessment methodologies for future anti-fibrotic therapy studies and correlating fibrosis with serum cardiac biomarkers and cardiovascular events.

Conditions

• Myocardial Fibrosis
• Heart Failure

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	68Ga-FAPI PET/CT	Positron emission tomography/computed tomography (68Ga-FAPI PET/CT)

Timeline

• Start date: 2025-11-17
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2025-12-22
• Last updated: 2025-12-29

Locations

1 site across 1 country: Portugal