Impact of Lipophilic Versus Hydrophilic Statin Administration on The Clinical Outcome and Cardiac Markers of Patients With Heart Failure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Left Ventricular End-systolic volume (LVESV)
研究概览
简要总结
There is a controversy whether statins are beneficial in patients with heart failure or not. Trials in which lipophilic statins have been used revealed positive results, unlike major studies where hydrophilic statins were administered. This trial is designed to compare the effects of lipophilic versus hydrophilic statin use in patients with heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years (of both sexes)
- •diagnosed with stable chronic heart failure NYHA class II-III
- •ejection fraction < 40 % as assessed by 2D echocardiography
- •who have been optimized on Guideline Directed treatment for heart failure for at least a month prior to enrolling.
排除标准
- •Known hypersensitivity to statin
- •Treatment with statins during the past month prior to study.
- •Serum creatinine > 3 mg/dl
- •Significant liver disease: liver enzymes 2.5 folds the upper normal limit
- •Malignancy
- •Pregnancy or lactation
研究组 & 干预措施
Lipophilic statin
Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.
干预措施: Atorvastatin (Drug)
Lipophilic statin
Atorvastatin 40 mg administered daily in addition to guideline directed therapy for heart failure.
干预措施: guideline directed therapy (Other)
Hydrophilic statin
Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
干预措施: Rosuvastatin (Drug)
Hydrophilic statin
Rosuvastatin 20 mg administered daily in addition to guideline directed therapy for heart failure.
干预措施: guideline directed therapy (Other)
结局指标
主要结局
Left Ventricular End-systolic volume (LVESV)
时间窗: 6 months
Left Ventricular Ejection Fraction (LVEF)
时间窗: 6 months
Left Ventricular End-diastolic volume (LVEDV)
时间窗: 6 months
cardiac markers
时间窗: 6 months
NT pro BNP (N-terminal prohormone of brain natriuretic peptide) sST2 (soluble suppression of tumorigenicity 2)
次要结局
- Minnesota Living with Heart Failure Questionnaire( MLHFQ)(6 months)
- Packer composite outcome(6 months)
研究者
Nouran Omar
Assistant Lecturer
Ain Shams University