35 Participants Needed

FAPI PET Scan for Heart Failure

JN
GT
Overseen ByGregorio Tersalvi, M.D
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technique called 68Ga-FAPI PET to evaluate its effectiveness for individuals with heart failure with preserved ejection fraction (HFpEF), a condition where the heart pumps normally but struggles to fill with blood. The study includes three groups: individuals with HFpEF and obesity, those with active cardiac sarcoidosis (a type of inflammatory heart disease), and healthy individuals for comparison. Potential participants include those recently diagnosed with HFpEF and a BMI of 30 or more, or those with a confirmed diagnosis of cardiac sarcoidosis. Participants should not have major chronic diseases or be on specific medications. As a Phase 2 trial, this research measures the imaging technique's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in heart disease diagnostics.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are in the Healthy Controls group, you should not be taking certain medications regularly, like anticoagulants or antihypertensives. If you are in the HFpEF or Cardiac Sarcoid groups, the protocol does not clearly state any medication restrictions.

What prior data suggests that the 68Ga-FAPI PET scan is safe for heart failure patients?

Research has shown that 68Ga-FAPI is generally safe for people. In studies, this treatment has helped visualize certain heart conditions. Although limited information exists on side effects for heart failure with preserved ejection fraction (HFpEF), earlier research has not identified major safety problems. As this trial is in an early stage, researchers are carefully monitoring the treatment for safety. Participants in this trial will be closely observed for any side effects.12345

Why are researchers excited about this trial?

The FAPI PET Scan for Heart Failure is unique because it uses a novel imaging agent, 68Ga-FAPI, to provide clearer insights into heart conditions, particularly heart failure with preserved ejection fraction (HFpEF) and cardiac sarcoidosis. Traditional heart failure treatments like beta-blockers and ACE inhibitors focus on managing symptoms and improving heart function, but they don't offer precise imaging of heart tissue. 68Ga-FAPI targets fibroblast activation protein, which is abundant in diseased heart areas, allowing for more detailed and accurate imaging of heart abnormalities. Researchers are excited about this approach because it could lead to better diagnosis and monitoring, potentially improving treatment strategies and outcomes for patients with heart conditions.

What evidence suggests that the 68Ga-FAPI PET scan is effective for heart failure?

Research has shown that the 68Ga-FAPI PET scan, which participants in this trial will undergo, might be useful for spotting early heart problems, particularly heart failure with preserved ejection fraction (HFpEF). Studies have found that this scan can detect early signs of fibrosis, a type of scarring in heart tissue associated with heart disease. This capability could help doctors identify heart issues before serious symptoms develop. One study suggested that 68Ga-FAPI PET scans can predict changes in heart function, making it a potential tool for early diagnosis and treatment planning. While more research is needed, these findings indicate that 68Ga-FAPI could play an important role in managing heart failure.26789

Who Is on the Research Team?

GT

Gregorio Tersalvi, M.D

Principal Investigator

Mayo Clinic

OA

Omar Abou Ezzeddine, M.D, M.S

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients over 30 years old with heart failure and preserved ejection fraction (HFpEF), experiencing shortness of breath during exertion. They must not have severe anemia, liver or kidney disease, active cancer, inflammatory/autoimmune diseases, a high BMI (≥30), or recent hospitalization.

Inclusion Criteria

I have not been hospitalized or had heart artery surgery in the last 30 days.
My BMI is 30 or higher.
I am 30 or older, get short of breath with exertion, and my heart pumps well.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline PET scans to assess 68Ga-FAPI uptake

1 week
1 visit (in-person)

Follow-up

Participants are monitored for changes in 68Ga-FAPI uptake over time

6 months
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 68Ga-FAPI
Trial Overview The study tests the effectiveness of a new imaging agent called 68Ga-FAPI using PET scans in patients with HFpEF to see how well it works in detecting heart issues related to their condition.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Obese subjects with HFpEF (heart failure with preserved ejection fraction)Experimental Treatment1 Intervention
Group II: Active cardiac sarcoidosisActive Control1 Intervention
Group III: Healthy subjectsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

Citations

A Study of 68Ga-Fibroblast Activation Protein Inhibitor ...68Ga-FAPI target-to-background ratio will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio.
FAPI PET Scan for Heart FailureThis Phase 2 medical study run by Mayo Clinic is evaluating whether 68Ga-FAPI will have tolerable side effects & efficacy for patients with Heart Failure.
A Study of 68GA-Fibroblast Activation Protein Inhibitor ...The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF). Participation ...
Potential of 68 Ga-FAPI-04 PET/MR to predict worsening ...This study aimed to investigate the potential of 68 Ga-FAPI-04 PET/MR in assessing and predicting renal function following STEMI.
How Rapidly Does the FAPI PET Signal Reverse Following ...The cardiac FAPI signal precedes functional myocardial changes, indicating that FAPI PET could detect early fibrosis in cardiac remodeling ...
A Study of 68Ga-Fibroblast Activation Protein Inhibitor ...... 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF). Official Title. A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast ...
A Study of 68GA-Fibroblast Activation Protein Inhibitor ...The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF). Participation ...
Application of Radionuclide Myocardial Imaging in the ...Heart failure with preserved ejection fraction (HFpEF) represents a major phenotype of heart failure and accounts for over 50% of clinical cases ...
Visualization of fibroblast activation using 68Ga-FAPI PET ...We aimed to assess 68 Ga-FAPI uptake in pulmonary veins as surrogate for ablation damage after PFA and cryoballoon ablation (CBA).
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security