An observational study in Myocardial Fibrosis and Heart Failure, sponsored by University of Coimbra. Recruiting at 1 site in Portugal. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-29.
Sponsored by University of Coimbra · Observational
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.
5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.
This study's planned enrollment of 30 is below the median of 200 across 1,679 observational studies indexed under Heart Failure.
Browse Heart Failure studies →University of Coimbra is the lead sponsor of 84 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Fifteen patients with HFrEF (non-ischemic dilated cardiomyopathy) and Fifteen patients with HFpEF (hypertrophic cardiomyopathy)
Exclusion Criteria:
patients with HFrEF (non-ischemic dilated cardiomyopathy) and HFpEF (hypertrophic cardiomyopathy)
Diagnostic Test: 68Ga-FAPI PET/CT
Positron emission tomography/computed tomography (68Ga-FAPI PET/CT)
68Ga-FAPI uptake
Comparison of myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with the non-invasive gold standard for fibrosis detection (Cardiac magnetic resonance with late gadolinium enhancement and extracellular volume)
Time frame: Baseline
68Ga-FAPI uptake
1. Identify suitable methodologies for assessing 68Ga-FAPI uptake for future studies evaluating the efficacy of anti-fibrotic therapies. 2. Correlate myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with serum markers of cardiac pathology. 3. Correlate myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with cardiovascular events over a 2-year follow-up.
Time frame: Baseline (1 & 2) and after 2 years (3)
Plan to share: Undecided
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University of Coimbra