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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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07083011
Enrollment
35
Registered
2025-07-24
Start date
2025-11-01
Completion date
2027-07-01
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure With Preserved Ejection Fraction

Brief summary

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

Interventions

DRUG68Ga-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

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volumeBaseline and 6 MonthsMyocardial 68Ga-FAPI volume will be determined by a PET (positron emission tomography) scan and measured in cm3
Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax)Baseline and 6 MonthsSUVmean and SUVmax will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio
Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptakeBaseline and 6 MonthsArea of 68Ga-FAPI will be determined by a PET (positron emission tomography) scan and measured as a % of polar map.
68Ga-FAPI target-to-background ratioBaseline and 6 Months68Ga-FAPI target-to-background ratio will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio.

Countries

United States

Contacts

CONTACTShawn Teal
teal.shawn@mayo.edu507-422-9485
CONTACTGregorio Tersalvi, M.D
tersalvi.gregorio@mayo.edu
PRINCIPAL_INVESTIGATOROmar Abou Ezzeddine, M.D, M.S

Mayo Clinic

PRINCIPAL_INVESTIGATORGregorio Tersalvi, M.D

Mayo Clinic

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026