A ComPrehensive, ObservationaL Registry of Heart FaiLure With Mid-range and Preserved EjectiON Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,065
- 试验地点
- 1
- 主要终点
- The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics.
研究概览
简要总结
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%).
Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in Turkey. Scarce data are available in the middle-east populations in general and Turkish patients in particular, who have different etiology, ethnic, cultural backgrounds and risk factors from those patients in the West. The aim of this study was to study Turkish patients with HFmrEF and HFpEF, and define their clinical characteristics and the signs and symptoms of heart failure, echocardiographic findings and medications at admission. With this national study, we will evaluate how recommendations of most recent European guidelines regarding pharmacological and non-pharmacological treatments are adopted in clinical practice. We will also evaluate the prevalence of the clinical profiles of patients with HFmrEF and HFpEF, according to the definitions proposed by the European Society of Cardiology, and to investigate their appropriateness in characterizing patients with different clinical presentations and needs.
Assessed outcomes included the causes of decompensation, use of medications, care quality indicators.
详细描述
Purpose:
To describe the demographic, clinical, and echocardiographic characteristics and management of outpatients heart failure (HF) with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) followed by a representative setting of cardiology centres.
Background:
About 50% of all patients suffering from HF exhibit a reduced ejection fraction (EF ≤ 40%), termed HFrEF. The others may be classified into HF with midrange EF (HFmrEF, EF = 40-50%) or preserved ejection fraction (HFpEF, EF ≥ 50%). Presentation and pathophysiology of HFmrEF and HFpEF is heterogeneous and its management remains a challenge since evidence of therapeutic benefits on outcome is scarce. Up to now, there are no large scale studies evaluating patients with HFmrEF and/or HFpEF in Turkey.
Objective:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Presentation to the hospital with clinical signs and symptoms of HF, according to the Framingham criteria.
- •Age≥ 18 years
- •BNP≥35 pg/ml and/or NT-proBNP≥125 pg/ml
- •Exclusion Criteria
- •<18 years old
- •LVEF < %40
- •Cor pulmonale
- •Known infiltrative or hypertrophic obstructive cardiomyopathy or known pericardial constriction;
- •Primary hemodynamically significant uncorrected valvular heart disease, prosthetic valve disease
- •Myocardial infarction in past 90 days
- •Coronary artery bypass graft surgery in past 90 days
- •Percutaneous coronary intervention in past 30 days;
- •Heart transplant recipient;
- •Currently implanted left ventricular assist device;
- •Stroke in past 90 days;
排除标准
- 未提供
结局指标
主要结局
The prevalence and management strategies of heart failure with midrange ejection fraction (HFmrEF) and heart failure with preserved ejection fraction (HFpEF) patients among participating cardiology outpatient clinics.
时间窗: Recruited and could be analysed at least 1065 patients after 3 months
Outcomes included the causes of decompensation, use of medications, care quality indicators.
次要结局
未报告次要终点
研究者
BÜLENT ÖZLEK
Principal Investigator
Muğla Sıtkı Koçman University