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临床试验/NCT05036967
NCT05036967已完成不适用

HEArt Failure Treatment Patterns: A Descriptive Study in COlombia

Bayer1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2021年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
Bayer
入组人数
1,000
试验地点
1
主要终点
Treatment initiation patterns

研究概览

简要总结

Researchers want to learn more about the treatments doctors choose to treat heart failure.

Heart failure means the heart isn't pumping as well as it should be. Heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death.

There are different types of treatments available for people who have heart failure, and these work in different ways. In this study, the researchers will collect information about Colombian patients who have heart failure.

The main purpose of this study is to identify patterns in the treatments that doctors first prescribe to heart failure patients in Columbia. To do this, the researchers will review information from the patients' medical records and from a drug-dispensing database.

The study will include adult patients who have been diagnosed with heart failure in Columbia from June 1st, 2019 to May 31st, 2020.

There will be no required visits, treatments, or procedures in this study. The researchers will collect information about the treatments the patients have been prescribed by their own doctors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Adult patients (older than 18 years) with a diagnosis of HF according to ICD-10 with a dispensing of some medicine and it is registered in the database of Audifarma S.A. during the observation period will be included

排除标准

  • Patients with Acute HF without prior diagnosis of HF

研究组 & 干预措施

Heart Failure (HF) patients

Patients diagnosed with incident HF, in an outpatient setting in Colombia during the time period of 01 JUN 2019 to 31 MAY 2020

干预措施: HF medication (Drug)

结局指标

主要结局

Treatment initiation patterns

时间窗: Database analysis: HF patients from June 1st, 2019 to May 31st, 2020

Treatment initiation patterns of patients with Heart Failure (HF) in an outpatient setting from Colombia.

次要结局

  • Clinical characteristics at baseline - Symptoms and signs: Dyspnea(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Symptoms and signs: Fatigue(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Symptoms and signs: Lower limb edema(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Laboratory data: Hemoglobin and hematocrit level(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Laboratory data: Left ventricular ejection fraction (LVEF)(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Laboratory data: EKG: main findings(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Laboratory data: Levels of NT-proBNP (N-terminal pro-B-type natriuretic peptide) or BNP (B-type natriuretic peptide)(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Clinical characteristics at baseline - Laboratory data: Serum Creatinine(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Subsequent treatment changes(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Betablockers BB(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor blockers ARB(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin-converting enzyme inhibitors ACEI(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Calcium-channel blockers CCB(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Mineralocorticoid receptor antagonist MRA(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Angiotensin receptor-neprilysin inhibitor ARNI(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)
  • Pattern of use of HF medications according to the classification of HF by left ventricular ejection fraction: Sodium-glucose co-transporter 2 inhibitors SGLT2i(Database analysis: HF patients from June 1st, 2019 to May 31st, 2020)

研究者

发起方
Bayer
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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