NOVEL-HF - Nationwide Registry of Patients With Heart Failure With Improved and Supranormal Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- All-cause mortality
研究概览
简要总结
NOVEL-HF is a multicenter, observational nationwide registry of HFimpEF and HFsnEF conducted in cooperation with the Scientific Platform of the Polish Society of Cardiology.
According to the current definitions the criteria for HFimpEF diagnosis include patients with HF with an initial left ventricular ejection fraction (LVEF) below 40%, with at least a 10% increase during follow-up, and with final values >40%. HFsnEF includes patients with HF whose LVEF values on echocardiography are >65%.
The patient data will be collected from standardized and anonymous forms via the Scientific Platform of the Polish Society of Cardiology. The NOVEL-HF registry will involve the complete clinical, laboratory, and echocardiographic characteristics, as well as introduced pharmacological treatment. The occurrence of end-points (all-cause mortality, cardiovascular mortality, HF decompensations, worsening of HF symptoms) will be assessed in short- and long-term follow-up.
In accordance with initial assumptions, 500 HFimpEF and 200 HFsnEF patients in all participating centers will be included.
Ethical approval was granted by the local Bioethics Committee.
详细描述
Heart failure with improved ejection fraction (HFimpEF) and heart failure with supranormal ejection fraction (HFsnEF) are new and poorly understood subtypes of heart failure with significant prognostic implications.
The primary goal of the proposed "Nationwide registry of patients with heart failure with improved and supranormal ejection fraction (NOVEL-HF)" is to comprehensively characterize the Polish population of patients with HFimpEF and HFsnEF.
The collected data will allow for understanding their etiology, determining detailed clinical characteristics, and predictors of mortality in both short and long-term follow-up. Once a sufficient number of patients are enrolled, new prognostic scoring scales will be developed based on NOVEL-HF registry data to aid in predicting prognosis in these patient groups.
Each participating center will enroll patients > 18 years old retrospectively from their internal databases based on the clinical and echocardiographic diagnosis of HFimpEF and HFsnEF, but also prospectively for six months from the NOVEL-HF joining with informed consent of the patients.
NOVEL-HF is a multicenter, observational nationwide registry of HFimpEF and HFsnEF conducted in cooperation with the Scientific Platform of the Polish Society of Cardiology.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •HFimpEF or HFsnEF diagnosis
排除标准
- 未提供
研究组 & 干预措施
Heart failure with improved ejection fraction
Patients with HF with an initial left ventricular ejection fraction (LVEF) below 40%, with at least a 10% increase during follow-up, and with final values >40%
Heart failure with supranormal ejection fraction
Patients with HF whose LVEF values on echocardiography are >65%
结局指标
主要结局
All-cause mortality
时间窗: 12 months
All-cause mortality
次要结局
- Cardiovascular mortality(12 months)
- HF decompensations(12 months)
- Worsening of HF symptoms(12 months)
研究者
Konrad Stępień
MD, PhD
Jagiellonian University