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NCT07083011RecruitingPhase 2

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

A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (estimated)
First submitted
16 Jul 2025
Start date
1 Nov 2025
Primary completion date
Jul 2027
Lead sponsor
Mayo Clinic
NCT number
NCT07083011

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 35
  • From 1 Nov 2025 to the primary completion date, Jul 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • 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)

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mayo Clinic in Rochester
Coordinator of this site? Confirm its status
RochesterUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.