Status:
RECRUITING
⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure
Lead Sponsor:
University of Coimbra
Collaborating Sponsors:
Unidade Local de Saúde de Coimbra, EPE
Conditions:
Myocardial Fibrosis
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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 i...
Eligibility 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).
Key Trial Info
Start Date :
November 17 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07296081
Start Date
November 17 2025
End Date
December 31 2028
Last Update
December 29 2025
Active Locations (1)
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1
Faculdade de Medicina da Universidade de Coimbra
Coimbra, Coimbra District, Portugal, 3000-548