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NCT Number: NCT07083011

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Amyloid Research Team

CONTACT

(507) 266-4426

Omar Abou Ezzeddine, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

68Ga-FAPI is a gallium-68 fibroblast activation protein inhibitor that will be injected into subjects during a PET (positron emission tomography) scan

Primary outcomes

  1. Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume

    Time frame: Baseline and 6 Months

    Myocardial 68Ga-FAPI volume will be determined by a PET (positron emission tomography) scan and measured in cm3

  2. Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax)

    Time frame: Baseline and 6 Months

    SUVmean and SUVmax will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio

  3. Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake

    Time frame: Baseline and 6 Months

    Area of 68Ga-FAPI will be determined by a PET (positron emission tomography) scan and measured as a % of polar map.

  4. 68Ga-FAPI target-to-background ratio

    Time frame: Baseline and 6 Months

    68Ga-FAPI target-to-background ratio will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio.

Study contacts

Contact information is provided by the study sponsor or research team.

Gregorio Tersalvi, M.D

CONTACT

[email protected]

Shawn Teal

CONTACT

[email protected]

507-422-9485

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 24, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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