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临床试验/NCT06459115
NCT06459115已完成不适用

Adherence to Medication in Patients With Acute Decompensated Heart Failure: a Cross-sectional Study at the Emergency Department (ADHF-ED= Adherence to Medication in Patients With Acute Decompensated Heart Failure at the Emergency Department)

Universität des Saarlandes1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Adherence to heart failure medication

研究概览

简要总结

Every day, patients present to emergency department due to acute heart failure. There are many causes for decompensation. One possible cause is a lack of adherence to heart failure medication (prognosis-improving medications and diuretics). The aim of this study is to directly measure adherence in patients with acute heart failure (gold standard of adherence measurement using liquid chromatography coupled to high-resolution mass spectrometry= LC-HRMS/MS) at the emergency department. Questionnaires are used to investigate possible factors influencing adherence.

详细描述

Several drugs has been shown to improve survival and to reduce the risk for hospitalization for acute heart failure (AHF) in patients with chronic heart failure.

Despite optimal drug treatment, patients with heart failure suffer one hospitalization for AHF every year on average with the requirement of intravenous diuretics. Hence, AHF is one of the leading causes for emergency department visits in elderly patients.

A possible cause for AHF in patients with known heart failure is nonadherence to drug treatment. Long-term-adherence to drugs of chronic diseases is low. Direct methods to assess adherence like the measurement drug levels or metabolites in body fluids are considered as the gold standard.

This study aimed to i) provide (direct measured) adherence rates of patients presented with AHF to the emergency department and ii) to identify patient-related factors with impact on adherence.

研究设计

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

入排标准

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

入选标准

  • •age ≥18 years of age
  • •known chronic heart failure irrespective of ejection fraction (heart failure with reduced, mildly reduced, or preserved ejection fraction)
  • •requirement of intravenous diuretics (outpatient or stationary treatment)
  • •stable heart failure medication >2 weeks
  • •≥1 sign of volume overload (peripheral edema, jugular venous distension, pulmonary rales, ascites, or demonstration of pulmonary venous congestion on chest X-ray)
  • •elevated natriuretic peptides (N-terminal pro brain natriuretic peptide= nt-pro-BNP ≥125 pg/ml)

排除标准

  • •- Not able to give written informed consent

结局指标

主要结局

Adherence to heart failure medication

时间窗: 1 day (cross-sectional)

Directly measured adherence rates (measurement of drug levels or metabolites in body fluids via toxicological analysis) of patients with acute heart failure at the emergency department \- If all prescribed drugs/metabolites for the treatment of heart failure were detectable in urine, the patient is "adherend". If 1 or at least 2 prescribed drugs were nondetectable in urine, the patient was classified as "partially adherend" and "non-adherend", respectively.

次要结局

  • Patients-related factor with impact on adherence (anxiety and depression)(1 day (cross-sectional))
  • Patients-related factors with impact on adherence (social support)(1 day (cross-sectional))
  • Patients-related factor with impact on adherence (dementia)(1 day (cross-sectional))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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