Gallium-68 FAPI PET/CT to find cardiac fibrosis in heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center prospective observational project will image adults with heart failure using 68Ga-FAPI PET/CT to identify fibroblast activation as a marker of active myocardial fibrosis. Participants include people with either reduced ejection fraction due to dilated cardiomyopathy or preserved ejection fraction with hypertrophic or diastolic abnormalities, and require recent echocardiography and cardiac MRI and non-obstructive coronary arteries. The approach aims to overcome limitations of cardiac MRI, which cannot reliably distinguish active from inactive fibrosis or detect very early fibrogenesis. Imaging results will be compared with existing clinical and imaging data to characterize FAPI uptake patterns and their potential role in monitoring or guiding anti-fibrotic therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 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 Criteria:

* Inability to provide informed consent;
* Inability to tolerate the supine position;
* Hemodynamic instability;
* Claustrophobia;
* Chronic kidney disease with glomerular filtration rate \<30 mL/min/1.73m²;
* Pregnant or breastfeeding women;
* 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).

Where it's running

• Faculdade de Medicina da Universidade de Coimbra
  Coimbra, Coimbra District, Portugal Recruiting

Study contacts

• Study coordinator: João Borges Rosa, MD
• Email: joaopedroborgesrosa@gmail.com
• Phone: +351239400400

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.