Actively Recruiting

Phase 2
Age: 18Years +
All Genders
Healthy Volunteers
NCT07083011

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

Led by Mayo Clinic · Updated on 2026-04-27

35

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 30 years or older with exertional dyspnea (NYHA II and III) and left ventricular ejection fraction 50% or higher
  • Body mass index (BMI) 30 or higher for HFpEF group
  • New diagnosis of HFpEF based on right heart catheterization showing elevated pulmonary capillary wedge pressure at rest or during exercise
  • Ambulatory patients aged 18 years or older with confirmed but untreated cardiac sarcoid and positive cardiac 18F-FDG PET scan within 30 days
  • Adults aged 30 years or older with no major chronic diseases and no regular intake of relevant medications for healthy control group
Not Eligible

You will not qualify if you...

  • Primary cardiomyopathy, pericardial disease, or moderate or greater valvular disease for HFpEF group
  • Dyspnea caused by lung disease or coronary artery disease
  • Severe anemia, liver, or renal disease
  • Active cancer
  • Systemic active inflammatory or autoimmune diseases such as rheumatoid arthritis or lupus
  • Recent hospitalization within 30 days or coronary revascularization within 90 days
  • Current use of SGLT2 inhibitors or GLP-1 agonists
  • Pregnancy or breastfeeding
  • Inability to tolerate lying flat for PET/CT or CMR scans
  • Contraindications for safe CMR scanning such as uncontrolled claustrophobia, cochlear implants, or implanted neural stimulators
  • Known allergy to gadolinium
  • Presence of implantable cardiac pacemaker, defibrillator, or mechanical valve
  • Already on immunosuppressive therapy for cardiac sarcoid
  • Severe liver or kidney disease with estimated glomerular filtration rate less than 30 or dialysis dependence
  • Body mass index 30 or higher for healthy controls

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Actively Recruiting

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Research Team

J

Jake Nemgar

CONTACT

G

Gregorio Tersalvi, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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