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临床试验/NCT01774890
NCT01774890已完成不适用

ST2, a Novel Biomarker for Cardiac Remodeling in Adults With Congenital Heart Disease

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
35
试验地点
1
主要终点
NYHA classification and/or 6 minute walk distance

研究概览

简要总结

The remarkable improvement in survival of children with congenital disease has led to a continuously growing number of adults with congenital heart disease in the developed world. Many of these patients had had cardiac surgery at early age, the may live for many years with pressure overload, volume overload, systolic or diastolic dysfunction, cyanosis or any combination of the above. These past and ongoing cardiac insults often result in significant cardiac remodeling. A biomarker for fibrosis and remodeling may have enormous clinical and prognostic value for these patients.

Serum biomarkers are now integrated in many fields in medicine. In cardiology, a number of biomarkers are used. In the last decade, our group has focused on the natriuretic peptides as markers for heart disease in infants and children. This resulted in many studies and more than 25 publications in the medical literature. We believe that the newly discovered cardiac marker, ST2, will emerge as an important addition to cardiac evaluation in the coming years.The aim of this study is to measure ST2 levels in patients with congenital right heart disease and correlate ST2 levels to clinical status, imaging and prognosis.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (age>18 y)
  • congenital heart disease

排除标准

  • Additional lung diseases, renal disease or inflammatory disease.
  • Patients who underwent therapeutic intervention between the MRI and the ST2 - measurements.
  • Pregnant women

结局指标

主要结局

NYHA classification and/or 6 minute walk distance

时间窗: six months

次要结局

  • Hemoglobin level(six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amiram Nir

Head, Adult Congenital Heart Disease Unit

Hadassah Medical Organization

研究点 (1)

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