Onset and Functional Consequences of Left Ventricular (LV) Fibrosis in Chronic Kidney
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- The effect of eGFR on heart muscle scarring (measured from cardiac MRI using T1 times).
研究概览
简要总结
This study aims to understand the onset an functional consequences of left ventricular interstitial fibrosis in patients with chronic kidney disease (stage 2 to 5), as well as assess whether transplantation results in a regression of cardiac fibrosis.Thus all patients will undergo: 1) a cardiac magnetic resonance imaging (MRI) scan to assess cardiac function and measure left ventricular interstitial fibrosis; 2) a cardiopulmonary stress echocardiogram to understand the functional consequences of fibrosis and rule out any underlying ischaemic heart disease; 3) a 24 hour holter monitor and electrocardiogram (ECG) to assess whether these patients are at higher risk of arrhythmia.
详细描述
Aim and objectives:
The primary objective of this study is to test the following hypotheses:
i) Patients with early stage chronic kidney disease (CKD) exhibit diffuse LV fibrosis manifest by prolonged native myocardial T1 times and expansion of the extracellular volume (ECV) measured on MRI with a graded relationship to eGFR (stage of CKD), independent of blood pressure and arterial stiffness.
The secondary research objectives are to test the following hypotheses:
i) Prolonged native myocardial T1 times are associated with impaired diastolic function, altered arterial-ventricular interaction and impaired effort tolerance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>18 years old
- •CKD stage 2, 3, 4 and 5
排除标准
- •Pregnancy
- •Ischaemic heart disease (angina, ACS)
- •Cerebral vascular disease
- •Peripheral vascular disease
- •Renovascular disease
- •Diabetes mellitus
- •Valvular heart disease (more than mild)
- •Established diagnosis of heart failure
- •Cannot have an MRI scan
结局指标
主要结局
The effect of eGFR on heart muscle scarring (measured from cardiac MRI using T1 times).
时间窗: One baseline visit only
eGFR is a measurement of kidney function. Heart muscle scarring levels can be derived from cardiac MRI using a technique called T1 mapping. T1 maps of the heart will be acquired using cardiac MRI. eGFR will be measured from a blood tests, using the MDRD equation. The relationship between the measured T1 times and eGFR will be analysed using statistical tests.
次要结局
- The relationship between prolonged myocardial T1 and diastolic function.(One baseline visit only)
- The relationship between prolonged myocardial T1 and effort tolerance.(One baseline visit only)
- The effect of renal transplantation on myocardial fibrosis.(Baseline visit (pre-operation), then follow up at 6 weeks and 1 year.)
研究者
Dr Manvir Kaur Hayer
Clinical Research Fellow
University Hospital Birmingham NHS Foundation Trust