RecruitingNCT07296081

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

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


Sponsor

University of Coimbra

Enrollment

30 participants

Start Date

Nov 17, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special PET/CT scan with a tracer called 68Ga-FAPI to detect scarring (fibrosis) in the hearts of people with heart failure, helping researchers better understand and potentially improve diagnosis. **You may be eligible if...** - You are 18 or older - You have signs and symptoms of heart failure - You have either preserved heart pumping function (HFpEF) with evidence of diastolic dysfunction, OR reduced heart pumping function (HFrEF with EF below 40%) **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had a recent heart attack (within 3 months) - You have severe kidney problems that prevent imaging - You have other conditions that would make the scan unsafe or uninterpretable Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST68Ga-FAPI PET/CT

Positron emission tomography/computed tomography (68Ga-FAPI PET/CT)


Locations(1)

Faculdade de Medicina da Universidade de Coimbra

Coimbra, Coimbra District, Portugal

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NCT07296081


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