跳至主要内容
临床试验/NCT02595814
NCT02595814终止不适用

International Registry to Assess mEdical Practice With lOngitudinal obseRvation for Treatment of Heart Failure

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 18,805 人开始时间: 2014年7月23日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
18,805
试验地点
1
主要终点
Percentage of patients who die during the index hospitalization

研究概览

简要总结

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

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

入选标准

  • Patients at least 18 years old, or older for those countries where the adult age is above 18 years of age, hospitalized with a primary diagnosis of acute heart failure.

排除标准

  • 1-Concomitant participation in any/a clinical trial with any investigational treatment (for any sponsor).
  • Use of investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.

结局指标

主要结局

Percentage of patients who die during the index hospitalization

时间窗: From admission to discharge of the patient's index hospitalization (minimum 24 hours)

Percentage of patients who are re-hospitalized by primary re-hospitalization reason (Cardiovascular and non-Cardiovascular)

时间窗: up to 3 years

Percentage of patients who die during the follow-up period post-discharge

时间窗: up to 3 years

Healthcare Resource Utilization assessed by number of patients with re-hospitalizations

时间窗: up to 3 years

Number of patients with different characteristics of post-discharge patient management

时间窗: up to 3 years

Number of patients with different characteristics of heart faliure (HF) at hospitalization

时间窗: From admission to discharge of the patient's index hospitalization (minimum 24 hours)

次要结局

  • Correlation ratio between practice patterns and outcomes(up to 3 years)
  • Health-related Quality of life (HRQoL) based on patient reported data as measured by EQ-5D and the Kansas City Cardiomyopathy Questionnaire (KCCQ) questionnaires(up to 3 years)
  • Caregiver burden based on Caregiver Burden Questionnaire -Heart Failure (CBQ-HF) and Work Productivity and Activity Impairment (WPAI) questionnaires(up to 3 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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