A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
Mayo Clinic · NCT07083011
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 2
- Target enrollment
- 35
- US sites recruiting
- 1
- Study start
- November 1, 2025
- Record last updated
- July 8, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
Being studied: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
Conditions: Heart Failure With Preserved Ejection Fraction
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
HFpEF Group Inclusion
- Patients aged ≥ 30 years old with exertional dyspnea (NYHA II and III) and LVEF ≥50%
- BMI ≥ 30
- New diagnosis of HFpEF based on RHC at baseline (elevated PCWP at rest and/or during exercise)
HFpEF Group Exclusion
- Primary cardiomyopathy or pericardial disease or ≥ moderate valvular disease
- Dyspnea due to lung disease or CAD
- Severe anemia, liver, or renal disease
- Active cancer
- Systemic active inflammatory or autoimmune disease (e.g. rheumatoid arthritis, SLE, etc.)
- Recent hospitalization (\< 30 days) or coronary revascularization (\< 90 days)
- Patients already taking SGLT2i and/or GLP-1A
- Pregnant or breastfeeding
- Inability to tolerate supine position for the PET/CT or CMR scans.
- Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
- Known gadolinium allergy
- Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.
Cardiac Sarcoid Group Inclusion
- Ambulatory patients aged ≥ 18 years old
- New referrals to the Sarcoid Clinic with a confirmed but untreated diagnosis of definite or probable CS based on 2014 HRS consensus (see Table 2)
- With a positive cardiac 18F-FDG PET scan within 30 days.
Cardiac Sarcoid Group Exclusion
- Already on immunosuppressive therapy
- Pregnant or breastfeeding
- Severe liver or renal disease (estimated GFR \< 30 or dialysis-dependent)
- Recent coronary revascularization (\< 90 days)
- Active cancer
- Known gadolinium allergy
- Inability to tolerate supine position for the PET/CT or CMR scans.
- Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
- Presence of implantable cardiac pacemaker or defibrillator or mechanical valve.
Healthy Controls Group Inclusion
- Adults ≥ 30 years old
- No major chronic disease (cardiopulmonary, inflammatory, autoimmune, cancer, renal or liver impairment, etc.)
- No intake of relevant medication, defined as regular intake of at least one of the following: anticoagulants, antiplatelets, antihypertensive / diuretics, antidiabetics, antiarrhythmic, immunosuppressants, chemotherapy, antibiotics/antivirals/antifungals
Healthy Controls Group Exclusion
- BMI ≥ 30
- Pregnant or breastfeeding
- Known gadolinium allergy
- Inability to tolerate supine position for the PET/CT or CMR scans.
- Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
Recruiting US locations
Mayo Clinic in Rochester
Rochester, MN 55905
Site contact: Amyloid Research Team · (507) 266-4426
Study contacts (from the official record)
- Shawn Teal · 507-422-9485 · teal.shawn@mayo.edu
- Gregorio Tersalvi, M.D · tersalvi.gregorio@mayo.edu
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