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临床试验/NCT06532825
NCT06532825招募中不适用

Cardiac Autonomic Dysfunction As a Sign of Irreversible Advanced Heart Failure

University Hospital Bispebjerg and Frederiksberg1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
number of rehospitalizations

研究概览

简要总结

The main hypothesis is that autonomic dysfunction cannot improve among patients reaching end-stage heart failure. To evaluate this, patients admitted with acute decompensated heart failure in Bispebjerg hospital, and history one or more admissions with the same condition within the prior year, will undergo repeated brief heart monitoring (10 min). Baseline recordings (at admission) will be compared with equivalent measurements before discharge to explore whether heart rate variability increases. Patients will be followed for six months after discharge from the hospital.

详细描述

If the patient accepts to participate and signed the project informed consent, their clinical record will be followed until the last patient included has been followed for six 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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-years age or older
  • admitted with acute decompensated heart failure for less than 48 h

排除标准

  • pacemaker
  • not signed informed consent
  • other heart rhythm than sinus rhythm or atrial fibrillation

结局指标

主要结局

number of rehospitalizations

时间窗: up to six months after discharge from index admission

number of emergency rehospitalizations, classified according to: 1. new decompensation of heart failure 2. side effects / complications to therapy for heart failure 3. other

次要结局

  • Heart rate Variability change from admission to discharge(repeated measurement at baseline (within 48h from time of index admission) and before discharge (estimated one week on average from index admission))

研究者

发起方
University Hospital Bispebjerg and Frederiksberg
申办方类型
Other
责任方
Principal Investigator
主要研究者

Helena DOMINGUEZ

MD, PhD, Consultant, Assoc.Prof.

University Hospital Bispebjerg and Frederiksberg

研究点 (1)

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