Lung Water By Ultra-Sound Guided Treatment To Prevent Death and Cardiovascular Complications in High Risk End Stage Renal Disease Patients With Cardiomyopathy (Lust Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 383
- 试验地点
- 21
- 主要终点
- Cumulative incidence of the composite outcome "death, myocardial infarction, heart failure".
研究概览
简要总结
Volume overload is a leading risk factor for death and cardiovascular events in end stage renal disease patients maintained on chronic dialysis, particularly in those with myocardial ischemia and heart failure which represent a substantial fraction of this population. Early identification of volume overload may prevent cardiovascular sequel in these patients but clinical signs of volume expansion are unsatisfactory to reliably identify patients at risk and to monitor them over time. On the other hand, however reliable, standard techniques for measuring extracellular or circulating (blood) volume do not convey information on fundamental heart function parameters that determine the individual haemodynamic tolerance to volume excess and the response to ultrafiltration, i.e. left ventricular (LV) filling pressure and LV function.
Extra-vascular lung water is critically dependent on these parameters and represents a proxy of both, circulating volume and LV filling pressure and function, and may therefore be a better criterion to identify patients at a higher risk of volume-dependent adverse clinical outcomes and to monitor the effect of therapy aimed at preventing these outcomes. A fast (< 5 min.), easy to learn, simple and non-expensive technique which measures extra-vascular lung water by using standard ultrasound (US) machines has been validated in dialysis patients. Whether systematic measurement of lung water by this technique may translate into better clinical outcomes in End Stage Renal Disease (ESRD) patients has never been tested.
The aim of this randomized clinical trial is that of testing a treatment policy guided by extra-vascular lung water measurements by ultrasound to prevent all-cause death, decompensated heart failure and non-fatal myocardial infarction in high risk dialysis patients with myocardial ischemia (a history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome documented by ECG recordings and cardiac troponins or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG) or overt heart failure (NYHA class III-IV).
详细描述
Randomization procedure: After enrollment, patients will be randomized in 2 groups: treatment and control. The randomization will be performed by centre, with a 1:1 allocation ratio, and it will be communicated by the coordinating centre in Reggio Calabria. An allocation concealment will be observed.
Warning: based on the principle "once randomized, always randomized", if a patient drops out the study he cannot simply be replaced by a new one. New patients must be randomized as well.
Validation of core lab data: The core data to be collected in the LUST project/subprojects should be validated by the following validation centres:
- CORE LUST STUDY DATA Echocardiographic data and US-lung data: Dr. Rosa Sicari and Dr. Luna Gargani, CNR Institute of Clinical Physiology of Pisa, Italy (rosas@ifc.cnr.it).
- ANCILLARY LUST PROJECTS Pulse Wave Velocity data (PWV): Prof. Gerard London, Service d'Hémodialyse, Hôpital F.H. Manhès, Fleury-Mérogis, France (glondon@club-internet.fr).
24 Ambulatory Blood Pressure Monitoring (ABPM) data: Prof. Francesca Mallamaci, Nephrology, Dialysis and Transplantation Unit and IFC-CNR, Reggio Calabria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age > 18 years
- •Dialysis vintage > 3 months
- •A history of myocardial infarction with or without ST elevation or unstable angina, acute coronary syndrome, documented by ECG recordings and cardiac troponins, or stable angina pectoris with documented coronary artery disease by prior coronary angiography or ECG or dyspnoea class III-IV NYHA
- •Written consent to take part in the study
排除标准
- •Cancer or other advanced non cardiac disease or comorbidity (e.g. end-stage liver failure) imposing a very poor short-term prognosis
- •Active infections or relevant inter-current disease
- •Inadequate lung scanning and echocardiographic studies
结局指标
主要结局
Cumulative incidence of the composite outcome "death, myocardial infarction, heart failure".
时间窗: All events occurred during 24 months of follow up will be assessed at 2 years after the start of the study. For Time-to-Event analyses, we will consider the time from the first visit to the first occurrence of death, or MI or heart failure.
Myocardial infarction and heart failure will be defined on the basis of international standard protocols. - The following figures we expect to occur in the two study arms: Active arm: 30% Control arm: 45%
次要结局
- Cardiovascular hospitalizations(First occurrence of cardiovascular hospitalization over a follow-up period of 24 months)
- Left ventricular mass index (LVMI)(LVMI will be measured by cardiologists at baseline, 6, 12 and 24 months)
- Left atrial volume(Left atrial volume (LAV) will be measured by cardiologists at baseline, 6, 12 and 24 months)
- All-cause hospitalizations(First occurrence of all-cause hospitalization over a follow-up period of 24 months)
- Left ventricular ejection fraction (LVEF)(LVEF will be measured by cardiologists at baseline, 6, 12 and 24 months)
- Diastolic function.(Diastolic function (E/E') will be measured by cardiologists at baseline, 6, 12 and 24 months)
研究者
Carmine Zoccali
MD, FASN, Professor of Nephrology (PG)
Istituto di Fisiologia Clinica CNR