NCT07296081Recruiting
⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure
Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 8 Dec 2025
- Start date
- 17 Nov 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Coimbra
- Diseases
- Heart failure
- NCT number
- NCT07296081
What you commit to
- Study type: Observational
- Planned participants: 30
- From 17 Nov 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Chronic kidney disease with glomerular filtration rate \<30 mL/min/1.73m²;
- 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).
Other
- Inability to provide informed consent;
- Inability to tolerate the supine position;
- Hemodynamic instability;
- Claustrophobia;
- Pregnant or breastfeeding women;
Who the study is looking for
- ≥ 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Faculdade de Medicina da Universidade de Coimbra Coordinator of this site? Confirm its status | Coimbra | Portugal | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.