A Three-Arm, Observational, Pilot Study of 68Ga-Fibroblast Activation Protein Inhibitor (FAPI) Positron Emission Tomography in Heart Failure
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume
研究概览
简要总结
The purpose of this study is to assess the performance of 68Ga- FAPI PET in heart failure with preserved ejection fraction (HFpEF)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •HFpEF Group Inclusion:
- •Patients aged ≥ 30 years old with exertional dyspnea (NYHA II and III) and LVEF ≥50%
- •New diagnosis of HFpEF based on RHC at baseline (elevated PCWP at rest and/or during exercise)
- •HFpEF Group
排除标准
- •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:
- •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)
研究组 & 干预措施
Obese subjects with HFpEF (heart failure with preserved ejection fraction)
干预措施: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) (Drug)
Active cardiac sarcoidosis
干预措施: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) (Drug)
Healthy subjects
干预措施: 68Ga-FAPI (gallium-68-labeled fibroblast activation protein inhibitor) (Drug)
结局指标
主要结局
Myocardial 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) volume
时间窗: Baseline and 6 Months
Myocardial 68Ga-FAPI volume will be determined by a PET (positron emission tomography) scan and measured in cm3
Mean Standardized Uptake Value (SUVmean) and Max Standardized Uptake Value (SUVmax)
时间窗: Baseline and 6 Months
SUVmean and SUVmax will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio
Area of 68Ga-FAPI (68Ga-Fibroblast Activation Protein Inhibitor) uptake
时间窗: Baseline and 6 Months
Area of 68Ga-FAPI will be determined by a PET (positron emission tomography) scan and measured as a % of polar map.
68Ga-FAPI target-to-background ratio
时间窗: Baseline and 6 Months
68Ga-FAPI target-to-background ratio will be determined by a PET (positron emission tomography) scan and measured as a dimensionless ratio.
次要结局
未报告次要终点
研究者
Omar Abou Ezzeddine
Principal Investigator
Mayo Clinic