Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

Not Applicable

• Conditions: Congestive Heart Failure
• Interventions: Drug: Atorvastatin; Drug: placebo for coenzyme Q10; Drug: Coenzyme Q10

• Registration Number: NCT01925937
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-08
• Study First Submitted: 2013-08-08
• Study First Submitted QC: 2013-08-16
• Last Update Submitted: 2013-08-16
• Study First Posted: 2013-08-20
• Last Update Posted: 2013-08-20
• Primary Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atorvastatin & placebo	placebo for coenzyme Q10	10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.
Coenzyme Q10 & Atorvastatin	Atorvastatin	10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.
Coenzyme Q10 & Atorvastatin	Coenzyme Q10	10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.
Atorvastatin & placebo	Atorvastatin	10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.

Primary Outcome Measures

Name	Time	Method
Change in cardiac Ejection Fraction (EF)	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).

Secondary Outcome Measures

Name	Time	Method
Change in New York Heart Association Function Class	Baseline for the first time and after 4 months for the second time	For the determination of change in New York Heart Association Function Class.it was determined two times .Baseline:at the beginning of study(before intervention)and the second time after 4 months(after intervention).

Trial Locations

Locations (1)

Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran; 🇮🇷 Isfahan, Iran, Islamic Republic of