Short-Term Outcomes of Patients With Heart Failure With Reduced Ejection Fraction (HFrEF) in View of Current Guideline-Directed Medical Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- Change in left ventricular ejection fraction
研究概览
简要总结
This prospective cohort study aims to evaluate short-term (3-month) clinical, renal, and functional outcomes in patients with heart failure with reduced ejection fraction treated with contemporary guideline-directed medical therapy at Assiut University Hospitals.
详细描述
Heart failure with reduced ejection fraction (HFrEF) remains a major cause of morbidity and mortality. Guideline-directed medical therapy (GDMT) with the four foundational drug classes has improved outcomes in clinical trials, but real-world short-term data from low- and middle-income settings are limited.
This observational study will include adult patients with chronic HFrEF (LVEF ≤40%) who are stable on or planned for initiation of guideline-directed medical therapy. Patients will be followed for 3 months with assessment of left ventricular ejection fraction, quality of life (KCCQ-12), renal function, and clinical events.
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 or older
- •Diagnosis of chronic HFrEF (LVEF ≤40%) documented by echocardiography
- •Stable on or planned initiation of guideline-directed medical therapy
- •Ability to provide informed consent
排除标准
- •- Acute decompensated heart failure requiring intravenous inotropes at enrollment
- •End-stage renal disease on dialysis
- •eGFR <20 mL/min/1.73 m² at baseline
- •Severe primary valvular disease requiring intervention
- •Life expectancy less than 3 months due to non-cardiac illness
研究组 & 干预措施
Single cohort: Patients with HFrEF on GDMT
Adult patients with chronic heart failure with reduced ejection fraction who are receiving or planned to receive guideline-directed medical therapy and will be followed for 3 months.
结局指标
主要结局
Change in left ventricular ejection fraction
时间窗: From baseline to 3 months
Change in left ventricular ejection fraction (LVEF) percentage measured by transthoracic echocardiography from baseline to 3 months.
次要结局
- Change in KCCQ-12 score(From baseline to 3 months)
- Change in eGFR(From baseline to 3 months)
- Hospitalization for worsening heart failure(Up to 3 months)
- Cardiovascular mortality(Up to 3 months)
- Worsening renal function(Up to 3 months)
研究者
Omar Nasr Sayed Ahmed
Resident Physician
Assiut University