A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
Primary cardiomyopathy or pericardial disease or ≥ moderate valvular disease
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)
Drug68Ga-FAPI is a gallium-68 fibroblast activation protein inhibitor that will be injected into subjects during a PET (positron emission tomography) scan
Treatment groups
35 Participants
are divided into 3 treatment groupsGroup A: Obese subjects with HFpEF (heart failure with preserved ejection fraction)Experimental treatment 1 intervention
Group B: Active cardiac sarcoidosisActive comparator 1 intervention
Group C: Healthy subjectsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline and 6 Months2
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
Time frame
Baseline and 6 Months3
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.
Time frame
Baseline and 6 Months4
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.
Time frame
Baseline and 6 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov