Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

Congestive Heart Failure Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01925937
• Other study ID #: 392219
• Status: Unknown status
• Phase: N/A
• First received: August 8, 2013
• Last updated: August 16, 2013
• Start date: June 2013

Study information

• Verified date: August 2013
• Source: Isfahan University of Medical Sciences
• Contact: Amin Nemati, MD
• Phone: 00989131009918
• Email: nemati[@]med.mui.ac.ir
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 30
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Drug:
• Atorvastatin

• Coenzyme Q10

• placebo for coenzyme Q10

Locations

Country	Name	City	State
Iran, Islamic Republic of	Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in cardiac Ejection Fraction (EF)	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).	Baseline for the first time and after 4 months for the second time
Secondary	Change in New York Heart Association Function Class	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).	Baseline for the first time and after 4 months for the second time