⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure (MY-FAPI)
Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: João Borges Rosa, MD
- Phone Number: +351239400400
- Email: joaopedroborgesrosa@gmail.com
Study Locations
-
-
Coimbra District
-
Coimbra, Coimbra District, Portugal, 3000-548
- Recruiting
- Faculdade de Medicina da Universidade de Coimbra
-
Contact:
- João Borges Rosa, MD
- Phone Number: +351239400400
- Email: joaopedroborgesrosa@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients with HFrEF and HFpEF
patients with HFrEF (non-ischemic dilated cardiomyopathy) and HFpEF (hypertrophic cardiomyopathy)
|
Positron emission tomography/computed tomography (68Ga-FAPI PET/CT)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
68Ga-FAPI uptake
Time Frame: Baseline
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
68Ga-FAPI uptake
Time Frame: Baseline (1 & 2) and after 2 years (3)
|
|
Baseline (1 & 2) and after 2 years (3)
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CE-113/2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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