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

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

Recruiting
18 years and older
All
Phase 2

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Overview

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

Eligibility

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)

Study details
    Heart Failure With Preserved Ejection Fraction

NCT07083011

Mayo Clinic

15 October 2025

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