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New treatment option for Heart Failure With Preserved Ejection Fraction
Official title A Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
ClinicalTrials.gov ID: NCT07083011
What this study is testing
What is 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor)?
68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) is an investigational medicine, being studied as a potential treatment for heart failure with preserved ejection fraction.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- 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
See the full 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.