Six Months Clinical and Echocardiographic Outcome of Angiotensin Receptor-Neprilysin Inhibitor (ARNI) LCZ696 Therapy in Heart Failure Patients With Reduced Ejection Fraction (HFrEF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.
研究概览
简要总结
To evaluate the clinical and echocardiographic outcome of LCZ696 therapy in HFrEF (NYHA Class II - IV and EF =≤ 40%).patients, in addition to the efficacy of LCZ696 in reducing mortality and rehospitalisation rate.
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
- •≥18 year old.
- •Functional class using New York Heart Association (NYHA) classification class II, III or IV %).
- •Left ventricular systolic dysfunction using transthoracic echocardiography with EF ≤ 40%.
- •Who was already taking ACE inhibitors or ARBs.
排除标准
- •Symptomatic hypotension.
- •Systolic blood pressure <100 mm Hg.
- •Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m
- •History of angioedema.
- •Hisotry of unacceptable side effects while on while on treatment with an ACE-inhibitor or ARBs.
研究组 & 干预措施
Single group study
干预措施: LCZ 696 (Drug)
结局指标
主要结局
Number of Participants That Had Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization.
时间窗: 6 Months after starting LCZ696 Therapy
Number of participants that had either CV death or HF hospitalization due to HF.
Change From Baseline to Month 6 for The Minnesota Living with Heart Failure Questionnaire (MLHFQ).
时间窗: 6 Months after starting LCZ696 Therapy
Change From Baseline to Month 6 for the Minnesota Living with Heart Failure Questionnaire (MLHFQ). The questionnaire was designed as a self-administered measure of the effects of heart failure and treatments for heart failure on patients' quality of life. The questionnaire has 21 items assess the impact of frequent physical symptoms of heart failure and the effects of heart failure on physical and social functions. The response scale for all 21 items on the MLHF is based on a 6-point ( from 0 to 5 ). Scores are transformed to a range of 0-105, in which higher scores reflect better health status.
次要结局
- Number of Patients with Changes in The Left Ventricular Systolic Function (EF).(6 Months after starting LCZ696 Therapy)
- Number of Patients - All-cause Mortality.(6 Months after starting LCZ696 Therapy)
- Number of Patients With First Confirmed Renal Dysfunction.(6 Months after starting LCZ696 Therapy)
研究者
Mohammed Alnims
Doctor, Investigator
Cairo University