68Ga‑FAPI PET imaging to detect fibroblast activity in HFpEF

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

This test uses a PET scan with 68Ga‑FAPI to see if it can identify fibroblast activity in people with HFpEF who are obese and have exertional breathlessness.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mayo Clinic (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Rochester, Minnesota)
• Trial ID: NCT07083011 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional imaging study gives participants an intravenous 68Ga‑FAPI tracer and performs PET imaging (with PET/CT and/or PET/CMR) to visualize fibroblast activation in the heart. Participants undergo right heart catheterization at baseline to confirm elevated pulmonary capillary wedge pressure at rest and/or during exercise, and imaging uptake will be compared with those hemodynamic findings and other cardiac imaging. Eligible subjects are adults ≥30 years with LVEF ≥50%, NYHA II–III symptoms, BMI ≥30, and a new RHC‑confirmed diagnosis of HFpEF; key exclusions include primary cardiomyopathy, moderate or greater valvular disease, active cancer or systemic inflammatory disease, recent hospitalization or revascularization, current SGLT2i/GLP‑1A therapy, pregnancy, or contraindications to CMR. The study is conducted at Mayo Clinic in Rochester, MN, with imaging and invasive hemodynamic correlation to test whether FAPI uptake corresponds to disease biology in HFpEF.

Who should consider this trial

Good fit: Ideal candidates are adults aged 30 or older with LVEF ≥50%, NYHA class II–III exertional dyspnea, BMI ≥30, a new HFpEF diagnosis confirmed by right heart catheterization showing elevated PCWP, and who can undergo PET and CMR without contraindication.

Not a fit: Patients with primary cardiomyopathy, significant valvular or pericardial disease, dyspnea primarily from lung disease or coronary disease, active cancer or systemic inflammatory disease, severe organ dysfunction, implanted pacemakers/defibrillators or mechanical valves, current SGLT2i/GLP‑1A therapy, pregnancy, or inability to tolerate imaging are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, this approach could provide a noninvasive imaging biomarker to identify myocardial fibroblast activation and help target or track therapies for HFpEF.

How similar studies have performed: Early FAPI PET work in oncology and small cardiac pilot studies has shown myocardial binding that correlates with fibrosis or remodeling, but applying FAPI PET specifically to HFpEF is relatively novel and not yet proven at scale.

Eligibility 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)

Where this trial is running

Rochester, Minnesota

• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)

Study contacts

• Principal investigator: Omar Abou Ezzeddine, M.D, M.S — Mayo Clinic
• Study coordinator: Jake Nemgar

Conditions Heart Failure With Preserved Ejection Fraction