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临床试验/NCT01925937
NCT01925937Unknown不适用

Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
30
试验地点
1
主要终点
Change in cardiac Ejection Fraction (EF)

研究概览

简要总结

The aim of this study is to compare the effect of addition of combination of Atorvastatin/CoenzymeQ10 to standard congestive heart failure (CHF) treatment versus addition of Atorvastatin alone on CHF outcomes.

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
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Documented Congestive hear failure
  • Ejection Fraction less than 40 percent
  • Compensated heart failure without hospital admission during previous three months
  • No change in type and dose of medications in the last months
  • New York Heart Association Function Class 2 to 4

排除标准

  • Acute coronary syndrome developing in the last month
  • Active myocarditis
  • Active pericarditis
  • Uncontrolled hypertension
  • Hepatic failure(Child B,C)
  • Pulmonary failure
  • Renal failure
  • Heart failure with KILLIP classification 3 and 4

研究组 & 干预措施

Coenzyme Q10 & Atorvastatin

Experimental

10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.

干预措施: Atorvastatin (Drug)

Coenzyme Q10 & Atorvastatin

Experimental

10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.

干预措施: Coenzyme Q10 (Drug)

Atorvastatin & placebo

Active Comparator

10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.

干预措施: Atorvastatin (Drug)

Atorvastatin & placebo

Active Comparator

10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.

干预措施: placebo for coenzyme Q10 (Drug)

结局指标

主要结局

Change in cardiac Ejection Fraction (EF)

时间窗: Baseline for the first time and after 4 months for the second time

For the determination of change in EF,cardiac EF was determined two times . Baseline :at the beginning of study(before intervention) and the second time after 4 months(after intervention).

次要结局

  • Change in New York Heart Association Function Class(Baseline for the first time and after 4 months for the second time)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amin Nemati

member of Isfahan Medical Students Research Committee

Isfahan University of Medical Sciences

研究点 (1)

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