Gallium-68 FAPI PET/CT to find cardiac fibrosis in heart failure
Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
This test will use a Gallium-68 FAPI PET/CT scan to see if it can detect active heart muscle fibrosis in adults with heart failure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Coimbra Academic / other |
| Locations | 1 site (Coimbra, Coimbra District) |
| Trial ID | NCT07296081 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with signs or symptoms of heart failure who have recent echocardiogram and cardiac MRI and either reduced LVEF with imaging evidence of dilated cardiomyopathy or preserved LVEF with structural/functional abnormalities consistent with hypertrophic/diastolic disease, and with normal coronary angiography/CT within six months.
Not a fit: People without heart failure, with active ischemic coronary disease, those unable to undergo PET/CT imaging or provide informed consent, or those who cannot travel to the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could provide a noninvasive way to detect active cardiac fibrosis earlier and help guide or monitor therapies to slow or reverse heart damage.
How similar studies have performed: Early pilot and small cohort studies have shown that 68Ga-FAPI PET can highlight myocardial fibroblast activity, but larger studies confirming clinical utility and impact on outcomes are still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Coimbra, Coimbra District
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.