Actively Recruiting
A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
Led by Mayo Clinic · Updated on 2026-04-27
35
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the performance of 68Ga-FAPI PET scans in people with heart failure with preserved ejection fraction (HFpEF). This study is a phase 2, observational pilot trial involving three groups: obese subjects with HFpEF, patients with active cardiac sarcoidosis, and healthy adult subjects. The study aims to better understand how this imaging technique works in these conditions. Participants will receive an injection of 68Ga-FAPI, a gallium-68-labeled fibroblast activation protein inhibitor, during a PET scan. The study includes three groups: obese HFpEF patients, cardiac sarcoidosis patients, and healthy controls. Each participant will undergo imaging at the start and again after six months to compare changes in 68Ga-FAPI uptake. During the study, researchers will measure several imaging outcomes such as myocardial 68Ga-FAPI volume, standardized uptake values, area of uptake, and target-to-background ratio at baseline and six months. Participants will be observed over this period with follow-up scans to monitor changes. The study will track safety and tolerability throughout the process, which is expected to last about six months per participant.
CONDITIONS
Brief Title
A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 30 years or older with exertional dyspnea (NYHA II and III) and left ventricular ejection fraction (LVEF) of 50% or higher
- Body mass index (BMI) of 30 or higher for HFpEF group
- New diagnosis of HFpEF based on right heart catheterization showing elevated pulmonary capillary wedge pressure at rest or during exercise
- Ambulatory patients aged 18 years or older with confirmed but untreated cardiac sarcoidosis and a positive cardiac 18F-FDG PET scan within 30 days
- Healthy adults aged 30 years or older with no major chronic diseases and no regular intake of relevant medications
You will not qualify if you...
- Primary cardiomyopathy, pericardial disease, or moderate or greater valvular disease in HFpEF group
- Dyspnea caused by lung disease or coronary artery disease
- Severe anemia, liver disease, or kidney disease
- Active cancer or systemic active inflammatory or autoimmune diseases such as rheumatoid arthritis or lupus
- Recent hospitalization within 30 days or coronary revascularization within 90 days
- Current use of SGLT2 inhibitors or GLP-1 agonists
- Pregnancy or breastfeeding
- Inability to tolerate lying flat for PET/CT or cardiac magnetic resonance scans
- Contraindications to safe cardiac magnetic resonance imaging, including uncontrolled claustrophobia, cochlear implant, or implanted neural stimulator
- Known allergy to gadolinium contrast
- Presence of implantable cardiac pacemaker, defibrillator, or mechanical heart valve
- Patients on immunosuppressive therapy in cardiac sarcoidosis group
- Healthy controls with BMI of 30 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline and 6 months
Participants undergo 68Ga-FAPI injection during PET scans to assess heart failure conditions.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
J
Jake Nemgar
G
Gregorio Tersalvi, M.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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