NCT07083011 · Mayo Clinic
A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
What this study is about
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
View original scientific description
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients aged ≥ 30 years old with exertional dyspnea (NYHA II and III) and LVEF ≥50%
- New diagnosis of HFpEF based on RHC at baseline (elevated PCWP at rest and/or during exercise) HFpEF Group
Exclusion criteria
- 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:
- 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
- Rochester, Minnesota
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations