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临床试验/NCT04451356
NCT04451356Unknown不适用

The Complex Evaluation of the Cardiovascular Risk in the Kidney Transplant Patients

Grigore T. Popa University of Medicine and Pharmacy1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年2月1日最近更新:
适应症

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:

  1. age>18 years;
  2. KT recipient.

The exclusion criteria are:

  1. metallic joint prostheses, cardiac stent or pacemakers, decompensated cirrhosis, pregnancy and limb amputations (due to bioimpedance technique limitations);
  2. no prior diagnosis of pulmonary fibrosis, pneumectomy or massive pleural effusion (due to lung ultrasonography limitations);
  3. active systemic infections (due to difficulties in the interpretation of nespecific inflammation biomarkers in this type of patients);
  4. absence of congenital heart disease;
  5. eGFR below 30 ml/min/1.73m2;
  6. 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

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

发起方
Grigore T. Popa University of Medicine and Pharmacy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dimitrie Siriopol

Associate Professor

Grigore T. Popa University of Medicine and Pharmacy

研究点 (1)

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