Myocardial Fibrosis in Heart Failure: A Pilot Study With 68Ga-FAPI PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 68Ga-FAPI uptake
研究概览
简要总结
Heart failure (HF) is a clinical syndrome with increasing incidence and prevalence, associated with high morbidity, mortality, and economic impact, despite therapeutic advances.
Myocardial fibrosis is a common feature across different pathophysiological processes and plays a key role in HF development, with growing research interest specifically in non-ischemic dilated cardiomyopathy (HFrEF phenotype) and hypertrophic cardiomyopathy (HFpEF phenotype). Given its potential reversibility with certain drugs, fibrosis is an attractive therapeutic target, requiring non-invasive methods to monitor fibrogenesis and treatment efficacy.
Cardiac magnetic resonance imaging (CMR) is the gold standard for detecting fibrosis but cannot distinguish between active and inactive fibrosis or detect early stages, limitations that may be addressed by gallium-68-labeled fibroblast activation protein inhibitor positron emission tomography/computed tomography (68Ga-FAPI PET/CT).
This single-center, prospective, observational pilot study aims primarily to assess myocardial fibrosis in patients with HFrEF (non-ischemic dilated cardiomyopathy) and a subtype of HFpEF (hypertrophic cardiomyopathy) using 68Ga-FAPI PET/CT compared to CMR.
Secondary objectives include developing 68Ga-FAPI uptake assessment methodologies for future anti-fibrotic therapy studies and correlating fibrosis with serum cardiac biomarkers and cardiovascular events.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old;
- •Signs and symptoms of heart failure (HF);
- •[Preserved left ventricular ejection fraction (LVEF) (≥50%) and Evidence of structural/functional abnormality consistent with diastolic dysfunction/increased ventricular filling pressures, including elevated natriuretic peptides and Imaging diagnosis of hypertrophic cardiomyopathy and Genetic diagnosis of hypertrophic cardiomyopathy due to sarcomeric gene mutation] OR [Reduced LVEF (≤40%) and Imaging diagnosis of dilated cardiomyopathy: left ventricular end-diastolic diameter >58 mm in men and >52 mm in women, and left ventricular volume ≥75 mL/m² in men and ≥62 mL/m² in women, not explained solely by loading conditions]
- •Recent transthoracic echocardiogram (< 3 months);
- •Recent cardiac magnetic resonance imaging (< 3 months).
- •Normal coronary angiogram or computed tomography coronary angiography within 6 months of enrolment
排除标准
- •Inability to provide informed consent;
- •Inability to tolerate the supine position;
- •Hemodynamic instability;
- •Claustrophobia;
- •Chronic kidney disease with glomerular filtration rate <30 mL/min/1.73m²;
- •Pregnant or breastfeeding women;
- •Malignant neoplasms within the past 5 years;
- •Significant primary valvular disease;
- •Significant atherosclerotic coronary artery disease;
- •Grade 2 or 3 arterial hypertension;
- •Presence of an implanted cardiac electrical device;
- •Recent hospitalization for heart failure (<30 days).
结局指标
主要结局
68Ga-FAPI uptake
时间窗: Baseline
Comparison of myocardial fibroblast activation identified by 68Ga-FAPI PET/CT with the non-invasive gold standard for fibrosis detection (Cardiac magnetic resonance with late gadolinium enhancement and extracellular volume)
次要结局
- 68Ga-FAPI uptake(Baseline (1 & 2) and after 2 years (3))
研究者
João Pedro Borges Rosa
MD, Cardiologist, PhD Student
University of Coimbra