Actively Recruiting
Myocardial Fibrosis in Heart Failure A Pilot Study Using 68Ga-FAPI PETCT
Led by University of Coimbra · Updated on 2025-12-29
30
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University of Coimbra
Lead Sponsor
U
Unidade Local de Saúde de Coimbra, EPE
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating myocardial fibrosis in patients with heart failure, focusing on those with non-ischemic dilated cardiomyopathy HFrEF phenotype and hypertrophic cardiomyopathy a subtype of HFpEF. The study explores the use of gallium-68-labeled fibroblast activation protein inhibitor positron emission tomographycomputed tomography 68Ga-FAPI PETCT compared to the current standard, cardiac magnetic resonance imaging CMR, to better detect and monitor fibrosis activity. This observational pilot study aims to improve non-invasive methods for assessing fibrogenesis and treatment effects. Participants will undergo 68Ga-FAPI PETCT scans to evaluate myocardial fibrosis. The study includes patients with preserved or reduced left ventricular ejection fraction meeting specific imaging and diagnostic criteria. Recent echocardiograms, cardiac magnetic resonance imaging, and normal coronary angiogram or CT coronary angiography are required within specified timelines. The study is single-center and prospective, focusing on developing new assessment methodologies for future anti-fibrotic therapies. During the study, participants will be monitored through imaging assessments at baseline and after two years to measure 68Ga-FAPI uptake. Researchers will also correlate imaging findings with serum cardiac biomarkers and cardiovascular events. The study requires participants to have stable conditions without recent hospitalizations for heart failure and includes safety monitoring concerning kidney function and tolerance to procedures. The total participation duration may span over two years with repeated evaluations.
CONDITIONS
Brief Title
⁶⁸Ga-FAPI PET/CT for Cardiac Fibrosis in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- Signs and symptoms of heart failure
- Preserved left ventricular ejection fraction (≥50%) with structural or functional abnormalities consistent with diastolic dysfunction or hypertrophic cardiomyopathy diagnosis
- Genetic diagnosis of hypertrophic cardiomyopathy due to sarcomeric gene mutation OR Reduced left ventricular ejection fraction (≤40%) with imaging diagnosis of dilated cardiomyopathy
- Recent transthoracic echocardiogram within 3 months
- Recent cardiac magnetic resonance imaging within 3 months
- Normal coronary angiogram or CT coronary angiography within 6 months before enrollment
You will not qualify if you...
- Inability to provide informed consent
- Inability to tolerate lying on your back (supine position)
- Hemodynamic instability
- Claustrophobia
- Chronic kidney disease with glomerular filtration rate below 30 mL/min/1.73m²
- Pregnant or breastfeeding women
- Malignant cancers within the past 5 years
- Significant primary heart valve disease
- Significant atherosclerotic coronary artery disease
- Grade 2 or 3 high blood pressure (arterial hypertension)
- Presence of an implanted cardiac electrical device
- Recent hospitalization for heart failure within 30 days
Research Team
J
João Borges Rosa, MD
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