Heart Failure With Preserved Ejection FractionPhase 2NCT07083011
A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
A Phase 2 study testing 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) in people with Heart Failure With Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF) Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure With Preserved Ejection Fraction
- What is being tested?
- 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gregorio Tersalvi, M.D contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Amyloid Research Team, (507) 266-4426
Omar Abou Ezzeddine, MD, MS
About this study
Official title: A Three-Arm, Observational, Pilot 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)
- Being tested
- 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Obese subjects with HFpEF (heart failure with preserved ejection fraction) | Experimental | Not described Receives: Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
| Active cardiac sarcoidosis | Active comparator | Not described Receives: Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
| Healthy subjects | Active comparator | Not described Receives: Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume
Myocardial 68Ga-FAPI volume will be determined by a PET (positron emission tomography) scan and measured in cm3
Measured: Baseline and 6 Months
Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax)
SUVmean and SUVmax will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio
Measured: Baseline and 6 Months
Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake
Area of 68Ga-FAPI will be determined by a PET (positron emission tomography) scan and measured as a % of polar map.
Measured: Baseline and 6 Months
68Ga-FAPI target-to-background ratio
68Ga-FAPI target-to-background ratio will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio.
Measured: Baseline and 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Nov 2025
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Preserved Ejection FractionStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abou Ezzeddine, Mayo Clinic
- Investigators
- Omar Abou Ezzeddine, M.D, M.S, Principal investigator, Mayo ClinicGregorio Tersalvi, M.D, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07083011
- Sponsor's protocol ID
- 25-004043
- Status last verified
- Jul 2026
- First submitted
- 16 Jul 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
- ClinicalTrials.gov ID
- NCT07083011
- Acronym / sponsor ID
- 25-004043
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese subjects with HFpEF (heart failure with preserved ejection fraction) | Experimental | Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
| Active cardiac sarcoidosis | Active comparator | Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
| Healthy subjects | Active comparator | Drug: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Active cardiac sarcoidosis, Healthy subjects, Obese subjects with HFpEF (heart failure with preserved ejection fraction) |
Primary outcome
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
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
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gregorio Tersalvi, M.D contact
Omar Abou Ezzeddine, M.D, M.S principal investigator
Mayo Clinic
Gregorio Tersalvi, M.D principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) in people with Heart Failure With Preserved Ejection Fraction, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shawn Teal (507-422-9485, teal.shawn@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume (time frame: Baseline and 6 Months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.