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

Overview

About this study

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

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Arm 1) HFpEF:
    • 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)
  • Arm 2) Cardiac Sarcoidosis:
    • 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)
  • Arm 3) Healthy controls:
    • 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 Criteria:

  • Arm 1) HFpEF:
    • 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
    • Contraindications for safe CMR scanning (e.g., uncontrolled claustrophobia, cochlear implant, implanted neural stimulator)
    • Known gadolinium allergy
  • Arm 2)  Cardiac Sarcoidosis:
    • ​​​​​​​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 allergy to gadolinium i.v. contrast
    • 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.
  • ​​​​​​​​​​​​​​​​​​​​​Arm 3) Healthy subjects
    • ​​​​​​​BMI ≥ 30
    • Pregnant or breastfeeding
    • Known allergy to gadolinium i.v. contrast
    • 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)

​​​​​​​Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 04/21/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Omar Abou Ezzeddine, M.D., M.S.

Contact us for the latest status

Contact information:

Heart Failure Research Team

(507) 422-6190

More information

Publications

Publications are currently not available