跳至主要内容
临床试验/NCT00690157
NCT00690157已完成不适用

National Polish Registry of Patients Referred for Heart Transplantation. POLKARD HF

National Institute of Cardiology, Warsaw, Poland5 个研究点 分布在 1 个国家目标入组 999 人开始时间: 2003年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
999
试验地点
5
主要终点
Death for all causes or urgent heart transplantation

研究概览

简要总结

Main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk factors and biological markers and verification of their prognostic value in Polish population.

详细描述

PART I 23.10.2008- 31.12.2005 Creation of the Polish national registry of patients referred for cardiac transplantation and after heart transplantation - including urgency of qualification and prognosis.

Main goal of the study is the risk stratification of patients with advanced heart failure referred for orthotopic heart transplantation (OHT) according to HFSS score, other risk factors and biological markers and verification of their prognostic value in Polish population.

All patients with advanced heart failure referred as potential candidates for OHT in all active transplantation centers were included in the registry.

PART II 1.01.2006 -30.11.2007 Since 2006 only patients which were definitely enlisted on the waiting list for heart transplantation were included in the registry

Clinical and laboratory data were recorded in the internet based form. Clinical data included the etiology of the disease, NYHA class, duration of symptoms pharmacological therapy, left ventricular ejection fraction, Ergospirometric maximal oxygen uptake (V02 max) results and right heart catheterization results , ecg data of leading heart rhythm and QRS duration >=0,12 s and other were stored Sodium ,NTproBNP levels and hs CRP plasma levels were recorded during first 48 hours of hospitalization. All patients were followed in a prospective cohort study until the end point : death or OHT , observations were censored at the end of the study. The urgency of OHT and death data was recorded by information from participating centers and national death registry quarries.

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
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • men and women aged >10 years with advanced heart failure
  • referred as potential candidates for orthotropic heart transplantation

排除标准

  • refusal to participate in the registry
  • not enlisted for heart transplantation (since 2006)

结局指标

主要结局

Death for all causes or urgent heart transplantation

时间窗: prospective progressive 1 to 48 months

次要结局

  • Death without heart transplantation(prospective , progressive 1 to 48 months)

研究者

发起方
National Institute of Cardiology, Warsaw, Poland
申办方类型
Other

研究点 (5)

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