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

NCT ID: NCT07083011

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-07-31

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 Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Active cardiac sarcoidosis

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Healthy subjects

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Omar Abou Ezzeddine

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Omar Abou Ezzeddine, M.D, M.S

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Gregorio Tersalvi, M.D

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jake Nemgar

Role: CONTACT

nemgar.jacob@mayo.edu

507-266-8774

Gregorio Tersalvi, M.D

Role: CONTACT

tersalvi.gregorio@mayo.edu

Facility Contacts

Amyloid Research Team

Role: primary

(507) 266-4426

Other Identifiers

25-004043

Identifier Type: -

Identifier Source: org_study_id