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Recruiting Phase 2 NCT07083011

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

Trial Parameters

Condition Heart Failure With Preserved Ejection Fraction
Sponsor Mayo Clinic
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 35
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11
Completion 2027-07
Interventions
68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)

Brief Summary

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

Eligibility 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: *

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