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

A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well a scan called 68Ga-FAPI PET works in people with heart failure whose hearts still pump a normal share of blood (HFpEF). It also includes people with cardiac sarcoidosis, a disease that causes swelling in the heart, and healthy adults.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • HFpEF group: Age 30 or older, with shortness of breath during activity and a heart pumping measure of at least 50%.
  • HFpEF group: Body mass index (BMI), a measure based on height and weight, of 30 or higher.
  • HFpEF group: Newly diagnosed HFpEF, confirmed by a heart catheter test showing high pressure at rest or during exercise.
  • Cardiac sarcoidosis group: Age 18 or older and able to walk.
  • Cardiac sarcoidosis group: Newly referred to the Sarcoid Clinic with untreated, definite or probable heart sarcoidosis that meets the study's diagnosis rules.
  • Cardiac sarcoidosis group: A positive heart 18F-FDG PET scan within 30 days.
  • Healthy group: Age 30 or older, with no major long-term illness.
  • Healthy group: No regular use of blood thinners, blood pressure drugs, water pills, diabetes drugs, heart rhythm drugs, immune-suppressing drugs, chemotherapy, or drugs that treat infections.

Who can't join

  • All groups: Pregnant or breastfeeding; allergy to gadolinium scan dye; unable to lie flat for scans; or unable to safely have a heart MRI, such as because of severe fear of tight spaces, a cochlear hearing implant, or an implanted nerve stimulator.
  • HFpEF and sarcoidosis groups: Active cancer, severe liver or kidney disease, or a procedure to restore blood flow to the heart within 90 days. For sarcoidosis, severe kidney disease means a filtering rate below 30 or needing dialysis.
  • HFpEF and sarcoidosis groups: A heart pacemaker, implanted heart shock device, or mechanical heart valve.
  • HFpEF group: Primary heart muscle disease, disease of the sac around the heart, at least moderate heart valve disease, severe anemia (too few healthy red blood cells), or breathlessness caused by lung disease or blocked heart arteries.
  • HFpEF group: Active body-wide inflammation or autoimmune disease, where the immune system attacks the body; or a hospital stay within 30 days.
  • HFpEF group: Already taking an SGLT2 inhibitor or GLP-1 agonist medicine.
  • Cardiac sarcoidosis group: Already taking medicine that lowers immune system activity.
  • Healthy group: BMI of 30 or higher.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

MN