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临床试验/NCT07465679
NCT07465679已完成不适用

Real-world Adoption of Clinical Treatment Guidelines for Patients With Heart Failure With Reduced Ejection Fraction in Treatment With Entresto in Romania (REACT-HFrEF-RO)

Novartis Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 2,508 人开始时间: 2026年1月28日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
2,508
试验地点
1
主要终点
Percentage of Patients Receiving all Four Guideline-recommended Therapeutic Classes for HFrEF

研究概览

简要总结

The aim of this study was to describe the real-world clinical profile, treatment patterns, and guideline alignment of patients with heart failure with reduced ejection fraction (HFrEF) treated with sacubitril/valsartan in routine clinical practice in Romania. The study used secondary use of data, with all analyses conducted on anonymized, pre-existing data collected for routine clinical and administrative purposes.

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

  • A recorded diagnosis of HFrEF.
  • At least one prescription of sacubitril/valsartan during the identification period.
  • Age ≥18 years at the index date.

排除标准

  • Patients who do not meet inclusion criteria.

研究组 & 干预措施

Sacubitril/Valsartan Cohort

Adults with a recorded diagnosis of HFrEF and ≥1 prescription of sacubitril/valsartan during the study period.

结局指标

主要结局

Percentage of Patients Receiving all Four Guideline-recommended Therapeutic Classes for HFrEF

时间窗: Up to approximately 5 years and 6 months

The four guideline-recommended therapeutic classes include sacubitril/valsartan, beta-blockers, mineralocorticoid receptor antagonists, and sodium-glucose cotransporter-2 (SGLT2) inhibitors.

次要结局

  • Duration of Sacubitril/Valsartan Treatment(Up to approximately 5 years and 6 months)
  • Number of Concomitant Cardiovascular Medications(Up to approximately 5 years and 6 months)
  • Percentage of Patients by Demographic Category(Up to approximately 5 years and 6 months)
  • Percentage of Patients by Clinical Characteristic Category(Up to approximately 5 years and 6 months)
  • Percentage of Patients Who Used Angiotensin-converting Enzyme (ACE) Inhibitors and/or Angiotensin Receptor Blockers Before Starting Sacubitril/Valsartan Treatment(Up to approximately 5 years and 6 months)
  • Percentage of Patients by Sacubitril/Valsartan Prescribed Dose at Treatment Initiation(Baseline)
  • Percentage of Patients by Dosing Frequency(Up to approximately 5 years and 6 months)
  • Percentage of Patients by Use of Individual Guideline-recommended Pharmacological Therapeutic Classes for HFrEF(Up to approximately 5 years and 6 months)
  • Percentage of Patients by Most Frequently Prescribed Concomitant Cardiovascular Medications(Up to approximately 5 years and 6 months)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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