Real World Experience in HFrEF Patients Treated With sAc/vaL in ITaly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 924
- 试验地点
- 1
- 主要终点
- Number of patients with Implanted prosthetic valve
研究概览
简要总结
The study is a cohort observational, retrospective, non-interventional study.
详细描述
Study period:
Index date: The index date were defined as the first date of the first prescription of Sacubitril/Valsartan during inclusion period and this were used to establish the beginning of the follow-up period.
Characterization period: 6 months period before the index date were used to characterize patients.
Follow-up period: Any patients has at least 1 year of follow-up. Follow-up period went from index date to June 2020.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive ambulatory patients with a diagnosis of HF that attended the Outpatient Clinics for HF management and who have been prescribed Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 (inclusion period) were included in the study. To allow for at least 1-year follow-up period for any patients, the observation period ended by 30 June
- •In detail, all patients attending by outpatient clinics for the diagnosis and treatment of HF in the Italian Centers involved, with:
- •age ≥18 years old AND
- •at least one prescription of Sacubitril/Valsartan from 01 October 2016 to 30 June 2019 were included in the study.
排除标准
- •Missing age or sex information.
研究组 & 干预措施
Sacubitril/Valsartan
Heart Failure (HF) patients treated with Sac/Val
干预措施: Sacubitril/Valsartan (Drug)
结局指标
主要结局
Number of patients with Implanted prosthetic valve
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Gender
时间窗: Baseline
To describe the demographics
Age
时间窗: Baseline
To describe the demographics
Number of patients with Ischemic heart disease
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with moderate or severe mitral or aortic valvulopathy
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with previous stroke
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with diabetes mellitus
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Duration of HF disease
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with PCI/CABG: Percutaneous coronary intervention/coronary artery bypass grafting
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with prior hospitalization for HF
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Chronic kidney disease (CKD)
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with ICD/CRT, Implantable Cardioverter Defibrillator/ Cardiac Resynchronization Therapy
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Atrial fibrillation
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with Hypertension
时间窗: Baseline
To evaluate clinical characteristics at baseline.
Number of patients with pharmacological treatments for HF
时间窗: throughout the study, approximately 3 years
To evaluate the pharmacological treatments for HF during characterization and follow-up.
次要结局
- Number of patients with initial and final doses(throughout the study, approximately 3 years)
- Number of patients with Non-maximum dose(throughout the study, approximately 3 years)
- Number of patients with hospitalization HF-related(throughout the study, approximately 3 years)
- Number of patients with Percutaneous Coronary Intervention (PCI)/coronary artery bypass grafting (CABG)(throughout the study, approximately 3 years)
- Number of patients with Device implantation (ICD/CRT)(throughout the study, approximately 3 years)
- Number of patients with ER visits HF-related(throughout the study, approximately 3 years)
- Number of deaths(throughout the study, approximately 3 years)
- Time to maximal dose prescribed(throughout the study, approximately 3 years)
- Number of patients with hospitalization related to other cardiovascular events(throughout the study, approximately 3 years)
- Number of patients with hospitalization related to non-CV cause(throughout the study, approximately 3 years)
- Number of patients with Valvular intervention(throughout the study, approximately 3 years)