68Ga-FAPI PET/CT scans to look for heart scarring in people with heart failure
Tests a PET/CT scan that looks for heart scarring in adults with heart failure.
Plain-language title generated from the registry record
Registry title: ⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure
Key facts
- Where
- Coimbra, PortugalSee the site
Where in Portugal
- Faculdade de Medicina da Universidade de CoimbraCoimbra, PortugalTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Coimbra
- Trial code
- NCT07296081
- Record updated
- 29 December 2025
- Original description
Heart failure (HF) is a clinical syndrome with increasing incidence and prevalence, associated with high morbidity, mortality, and economic impact, despite therapeutic advances.Read full original descriptionShow less
Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
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.
Inclusion: ≥ 18 years old; Signs and symptoms of heart failure (HF); [Preserved left ventricular ejection fraction (LVEF) (≥50%) and Evidence of structural/functional abnormality consistent with diastolic dysfunction/increased ventricular filling pressures, including elevated natriuretic peptides and Imaging diagnosis of hypertrophic cardiomyopathy and Genetic diagnosis of hypertrophic cardiomyopathy due to sarcomeric gene mutation] OR [Reduced LVEF (≤40%) and Imaging diagnosis of dilated cardiomyopathy: left ventricular end-diastolic diameter >58 mm in men and >52 mm in women, and left ventricular volume ≥75 mL/m² in men and ≥62 mL/m² in women, not explained solely by loading conditions]; Recent transthoracic echocardiogram (< 3 months); Recent cardiac magnetic resonance imaging (< 3 months); Normal coronary angiogram or computed tomography coronary angiography within 6 months of enrolment.
Exclusion: Chronic kidney disease with glomerular filtration rate <30 mL/min/1.73m²; Malignant neoplasms within the past 5 years; Significant primary valvular disease; Significant atherosclerotic coronary artery disease; Grade 2 or 3 arterial hypertension; Presence of an implanted cardiac electrical device; Recent hospitalization for heart failure (<30 days); Inability to provide informed consent; Inability to tolerate the supine position; Hemodynamic instability; Claustrophobia; Pregnant or breastfeeding women.