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Taking people in United StatesPhase 2

Imaging Heart Failure With Preserved Ejection Fraction Using a PET Scan Tracer

Tests a PET scan tracer, 68Ga-FAPI, in adults with heart failure.

Plain-language title generated from the registry record
Registry title: A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

Key facts

Where
Rochester, United StatesSee the site
Phase
Phase 2

Where in United States

  • Mayo Clinic in RochesterRochester, United StatesTaking people

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Trial details

Who runs it
Mayo Clinic
Trial code
NCT07083011
Record updated
8 July 2026
Original description
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)Read full original descriptionShow less

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

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

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).

ClinicalTrials.gov NCT07083011