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| Name | Class |
|---|---|
| Unidade Local de Saúde de Coimbra, EPE | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with HFrEF and HFpEF | patients with HFrEF (non-ischemic dilated cardiomyopathy) and HFpEF (hypertrophic cardiomyopathy) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI PET/CT | Diagnostic Test | Positron emission tomography/computed tomography (68Ga-FAPI PET/CT) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 68Ga-FAPI uptake | Comparison of myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with the non-invasive gold standard for fibrosis detection (Cardiac magnetic resonance with late gadolinium enhancement and extracellular volume) | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 68Ga-FAPI uptake |
|
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Inclusion Criteria:
Exclusion Criteria:
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Fifteen patients with HFrEF (non-ischemic dilated cardiomyopathy) and Fifteen patients with HFpEF (hypertrophic cardiomyopathy)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| João Borges Rosa, MD | Contact | +351239400400 | joaopedroborgesrosa@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculdade de Medicina da Universidade de Coimbra | Recruiting | Coimbra | Coimbra District | 3000-548 | Portugal |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Baseline (1 & 2) and after 2 years (3) |