Recruiting NCT07083011

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

Phase II Interventional Heart Failure With Preserved Ejection Fraction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor).
Who it may be relevant to: Registry conditions: Heart Failure With Preserved Ejection Fraction. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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)

Drug 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

Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume [Time frame: Baseline and 6 Months]
Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax) [Time frame: Baseline and 6 Months]
Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake [Time frame: Baseline and 6 Months]
68Ga-FAPI target-to-background ratio [Time frame: Baseline and 6 Months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

United States · 1 center

NCT: NCT07083011 · 25-004043