Early Treatment of Heart Failure: a Non-Interventional Observational Study of Italian Patients With Heart Failure and Initiated on Dapagliflozin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 252
- 试验地点
- 1
- 主要终点
- Dapagliflozin treatment pattern
研究概览
简要总结
This is an observational, non-interventional, longitudinal prospective descriptive study including participants diagnosed with Heart Failure with reduced Ejection Fraction (HFrEF) in Italy and initiated on treatment with dapagliflozin according to the approved HFrEF indication. The study is aimed at providing insights into real-world drug utilization and treatment patterns of dapagliflozin in the Italian HFrEF setting, as well as patient-reported outcomes including quality of life.
详细描述
Heart failure (HF) is a significant burden for public health, affecting more than 63 million people worldwide and expected to increase as the population ages; in Italy, the estimated prevalence of HF is 1-3% and the incidence rate 2-5 cases per 1000 persons per year. Despite advancements in treatment, a HF diagnosis still leads to significant morbidity and mortality and impacts on patients' quality of life (QoL). Dapagliflozin is the first in a novel class of glucose-lowering agents known as sodium-glucose co-transporter-2 (SGLT2) inhibitors, approved for the treatment of Heart Failure with reduced Ejection Fraction (HFrEF). As with all new drugs introduced into clinical practice, there is a strong scientific interest in producing evidence from observational studies regarding the use of dapagliflozin for the treatment of HFrEF in real-world settings with detailed clinical data on heart failure symptoms, outcomes, and health-related QoL.
The overall aim of this observational study is to describe the characteristics of patients in Italy initiating dapagliflozin for the treatment of HFrEF and to provide early insights into real-world dapagliflozin treatment patterns (primary objectives) as well as patient-reported outcomes including quality of life (secondary objectives).
This study is part of a multicountry study programme, including similar studies that will be conducted in other countries with similar objectives. Data from each of the individual studies may be combined in a pooled analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Age equal or above 18 years old at the initiation of treatment with dapagliflozin
- •Participant received/receiving treatment with dapagliflozin for Heart Failure with reduced Ejection Fraction (HFrEF) in accordance with the approved local dapagliflozin product label, i.e. with an ejection fraction of 40 percent or less
- •Signed and dated informed cconsent obtained prior to enrollment into the study
排除标准
- •Participant is enrolled less than 14 days or more than 45 days following the initiation of treatment with dapagliflozin
- •Prior treatment with dapagliflozin or other treatment with a medicine of the same drug class (sodium-glucose co-transporter-2 - or SGLT2 - inhibitors)
- •Initiation of dapagliflozin outside of the approved local dapagliflozin product label for HFrEF
- •Diagnosis of Type 1 Diabetes
研究组 & 干预措施
Single-cohort
Patients initiated on dapagliflozin according to the approved indication for heart failure with reduced ejection fraction (HFrEF) and current medical practice
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Dapagliflozin treatment pattern
时间窗: 12 months from prescription of dapagliflozin
Treatment discontinuation events for dapagliflozin
Baseline characteristics of participants
时间窗: Baseline (enrollment)
Demographic and clinical characteristics at baseline of study participants
Other medications treatment patterns
时间窗: 12 months from prescription of dapagliflozin
Treatment change events for other medications for heart failure and glucose-lowering medications
次要结局
- Patient Reported Outcome: Kansas City Cardiomyopathy Questionnaire (KCCQ)(Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation))
- Patient Reported Outcome: Medication Adherence Report Scale (MARS-5)(Baseline (enrollment), Follow-up (3, 6, 12 months after treatment initiation))