The Complex Evaluation of the Cardiovascular Risk in the Kidney Transplant Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Composite Renal Outcome
研究概览
简要总结
Kidney transplantation (KT) represents the best treatment for patients with end-stage kidney disease, being associated with improved outcomes and reduced mortality. Although the survival benefit with KT is mostly attributable to reduction in cardiovascular (CV) disease, KT recipients continue to remain at higher risk for CV-related morbidity and mortality when compared with the general population. Additionally, CV events represent the leading cause of death in KT recipients with a functioning allograft. KT recipients have high rates of hospitalization for myocardial infarction, congestive heart failure, dysrhythmias, stroke, malignant hypertension, and cardiac arrest. Significant amounts of research have been aimed at reducing event rates, primarily aimed at understanding prevalent risk factors, defining outcomes, and application of guideline-based care.
The post-KT milieu represents the confluence of several traditional and nontraditional CV risk factors contributing to the significant CV risk in this population. CV disease remains an understudied and undertreated source of morbidity and mortality in KT patients. Patients with chronic kidney disease (CKD) are generally excluded from major cardiovascular outcome trials, and this phenomenon of aversion to including patients with CKD in CV trials and providing appropriate goal-directed medical and interventional therapies (renalism) extends into KT .
The main aim of this study is to evaluate holistically the CV risk in a KT population. The investigators will compare bioimpedance spectroscopy derived fluid status parameters (overhydration, total body water, extracellular water and intracellular water) with clinical evaluation, lung ultrasonography, pulse wave velocity, different biomarkers, and echocardiographic characteristics and also to determine the impact of these parameters on renal and CV outcomes in the same population.
详细描述
• Patients:
The inclusion criteria are:
- age>18 years;
- KT recipient.
The exclusion criteria are:
- metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
- no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due to lung ultrasonography limitations);
- active systemic infections (due to difficulties in the interpretation of nespecific inflammation biomarkers in this type of patients);
- absence of congenital heart disease;
- eGFR below 30 ml/min/1.73m2;
- KT vintage of at least 6 months.
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 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age>18 years;
- •Kidney Transplant Recipient.
排除标准
- •metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
- •no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due to lung ultrasonography limitations);
- •active systemic infections (due to difficulties in the interpretation of nespecific inflammation biomarkers in this type of patients);
- •absence of congenital heart disease;
- •eGFR below 30 ml/min/1.73m2;
- •KT vintage of at least 6 months.
结局指标
主要结局
Composite Renal Outcome
时间窗: 36 months
Doubling of creatinine or dialysis initiation.
Composite Cardiovascular Outcome
时间窗: 36 months
Time to first non-fatal myocardial infarction, non-fatal stroke, hospitalization for heart failure, or cardiovascular death
次要结局
- Chronic kidney disease progression(36 months)
- Proteinuria progression(36 months)
研究者
Dimitrie Siriopol
Associate Professor
Grigore T. Popa University of Medicine and Pharmacy
