BRING-UP 3 Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 187
- 主要终点
- Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF
研究概览
简要总结
The aim of this observational study is to assess the level of adherence to guideline recommendations regarding the management of patients with Heart Failure with Reduced Ejection Fraction (HFrEF); - the safety profile of the implementation of recommended treatments; - to monitor treatment patterns of patients with acute hert failure (HF); - to monitor treatment patterns of all patients with chronic HF irrespective of the level of ejection fraction (EF).
详细描述
Observational, prospective, multicenter study conducted in a large, representative sample of Italian cardiology centers.
Phases 1:
- First educational intervention to discuss the recommendations of guidelines and treatment patterns in specific phenotypes of patients.
- Data collection for 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening).
- Evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up.
- Second educational intervention to share the results of the first enrollment period of the study focusing the attention on existing gaps between guidelines recommendations and clinical practice.
- New data collection for other 3 months or up to 30 consecutive patients with chronic HF or acute HF (both de novo and worsening).
- Additional evaluation of the primary and secondary end-points of the study at 6 months after enrollment. Modifications of treatments will be monitored during the 6 months follow-up.
- 12-month follow-up for all patients included in both enrolment phases of the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 ≥18 years old.
- •Males and females at birth.
- •Any ejection fraction level (level of ejection fraction measured in the 6 months preceding enrollment).
- •Ambulatory chronic HF or Hospitalized de-novo or worsening HF.
- •Signed informed consent
- •Diagnosis will be made by the local attending physician following the ESC guidelines recommendations.
排除标准
- •Active neoplasia or very severe disease compromising short-medium term life expectancy.
- •Participation in interventional studies.
- •Patients already enrolled into the study from another participating center or in the previous enrolling phase.
结局指标
主要结局
Rate of adherence to Guideline-Directed Medical Therapy (GDMTs) in HFrEF
时间窗: 6 months
To assess the rate of patients with HFrEF appropriately treated with the 4 therapeutic pillars \[Angiotensin Converting Enzyme Inhibitors (ACE-i)/Angiotensin Receptor Blockers (ARBs)/Angiotensin Receptor/Neprilysin Inhibitor (ARNI), betablockers, mineralocorticoid receptor antagonist (MRAs), Sodium-Glucose Co-Transporter-2 (SGLT2i)\] recommended by current European Society of Cardiology (ESC) 2021 guidelines. Patients with a documented contraindication to one or more of the 4 recommended therapeutic pillars will be included in the group of appropriately treated patients.
次要结局
- Treatment patterns of patients with Acute Heart Failure (AHF) irrespective of the level of EF(6 months)
- All cause and specific causes of death and hospitalization (Exploratory endpoint)(12 months)
- Rate of patient achieving appropriate dosages of GDMTs(6 months)
- Treatment patterns of patients with Heart failure with mildly reduced ejection fraction (HFmrEF) and Heart failure with preserved ejection fraction (HFpEF)(6 months)