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RecruitingAccepts healthy volunteersPhase 2

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

Mayo Clinic · NCT07083011

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 2
Target enrollment
35
US sites recruiting
1
Study start
November 1, 2025
Record last updated
July 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

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

Conditions: Heart Failure With Preserved Ejection Fraction

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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

  • 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)

Recruiting US locations

  • Mayo Clinic in Rochester

    Rochester, MN 55905

    Site contact: Amyloid Research Team · (507) 266-4426

Study contacts (from the official record)

  • Shawn Teal · 507-422-9485 · teal.shawn@mayo.edu
  • Gregorio Tersalvi, M.D · tersalvi.gregorio@mayo.edu
A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI)… (NCT07083011) | Bored Studies