Recruiting
Phase 2

68Ga-FAPI PET

Sponsor:

Mayo Clinic

Code:

NCT07083011

Conditions

Heart Failure With Preserved Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

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

Study Details

Brief summary:

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

Conditions

Heart Failure With Preserved Ejection Fraction

Study ID

NCT07083011

Start date

Nov 1, 2025

Status verified date

Jul, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

35 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Obese subjects with HFpEF (heart failure with preserved ejection fraction)

active comparator: Active cardiac sarcoidosis

active comparator: Healthy subjects

Interventions

68Ga-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

Primary outcome measure

  • Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume [ Time Frame: Baseline and 6 Months ]
  • Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax) [ Time Frame: Baseline and 6 Months ]
  • Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake [ Time Frame: Baseline and 6 Months ]
  • 68Ga-FAPI target-to-background ratio [ Time Frame: Baseline and 6 Months ]

Central Contacts and Locations

Central contacts

Shawn Teal

507-422-9485teal.shawn@mayo.edu

Gregorio Tersalvi, M.D

tersalvi.gregorio@mayo.edu

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Amyloid Research Team

(507) 266-4426

Principal Investigator:

Omar Abou Ezzeddine, MD, MS

More Information

Sponsor

Mayo Clinic

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-07-08.