MAgnetic Resonance Non-contrast Assessment of Cardiac Microvascular Dysfunction in Patients With Heart Failure With PrEserveD Ejection Fraction (MAPPED)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Peak stress perfusion
研究概览
简要总结
Heart failure with preserved ejection fraction (HFpEF) causes hospitalizations, premature mortality and high health care costs. This is also due to poor understanding of HFpEF pathogenesis and, thus, lack of specific therapies. Prompted by the recent demonstration that HFpEF clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. Cardiac Magnetic Resonance (CMR) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. In HFpEF patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
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
- •Age greater of or equal to 18 years at enrolment
- •Able to provide written informed consent
- •Diagnosis of HFpEF as defined by the 2016 ESC Guidelines (only for HFpEF group)
排除标准
- •Pregnancy or breastfeeding
- •Absolute contraindication to adenosine perfusion cardiac MRI (including uncontrolled asthma and severe chronic kidney failure, defined as glomerular filtration rate < 30ml(min/kg)
- •Atrial fibrillation
- •Previous chemotherapy and/or mediastinal radiotherapy
- •Known CAD
- •Diabetes Mellitus
- •Systemic inflammatory diseases
- •Any other medical condition which, in the Investigators' opinion, could affect the study results
- •Only for control group: any known cardiac, pulmonary, haematological or neoplastic known medical condition and/or any chronic therapy.
结局指标
主要结局
Peak stress perfusion
时间窗: at recruitment (cross sectional)
Detection of impaired cardiac microvascular function (defined as a T1 mapping reactivity - delta T1m before and during stress test= 3.0 +/-0.9%) in HFpEF patients compared to healthy controls.
Extracellular volume
时间窗: at recruitment (cross sectional)
Detection of higher cardiac diffuse fibrosis (defined as increased extracellular volume, measured by T1 mapping as per international guidelines, expressed as % ) in HFpEF patients compared to healthy controls.
次要结局
未报告次要终点