RecruitingPhase 2NCT07083011

A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

Sponsor

Mayo Clinic

Enrollment

35 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Heart Failure With Preserved Ejection Fraction

Summary

The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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)
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.
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

Exclusion Criteria26

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.
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.
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)

Interventions

DRUG68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)

68Ga-FAPI is a gallium-68 fibroblast activation protein inhibitor that will be injected into subjects during a PET (positron emission tomography) scan