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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Obese subjects with HFpEF (heart failure with preserved ejection fraction) |
|
|
|
Active Comparator Active cardiac sarcoidosis |
|
|
|
Active Comparator Healthy subjects |
|
Recruiting Locations
Rochester, Minnesota 55905
Amyloid Research Team
(507) 266-4426
More Details
- Status
- Recruiting
- Sponsor
- Mayo Clinic