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

Purpose

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

Condition

  • Heart Failure With Preserved Ejection Fraction

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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 Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Obese subjects with HFpEF (heart failure with preserved ejection fraction)
  • 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
Active Comparator
Active cardiac sarcoidosis
  • 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
Active Comparator
Healthy subjects
  • 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

Recruiting Locations

Mayo Clinic in Rochester
Rochester, Minnesota 55905
Contact:
Amyloid Research Team
(507) 266-4426

More Details

Status
Recruiting
Sponsor
Mayo Clinic

Study Contact

Shawn Teal
507-422-9485
teal.shawn@mayo.edu