Purpose

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

Condition

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.