Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Isfahan University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
Amin Nemati, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01925937
First received: August 8, 2013
Last updated: August 16, 2013
Last verified: August 2013

August 8, 2013
August 16, 2013
June 2013
January 2014   (final data collection date for primary outcome measure)
Change in cardiac Ejection Fraction (EF) [ Time Frame: Baseline for the first time and after 4 months for the second time ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01925937 on ClinicalTrials.gov Archive Site
Change in New York Heart Association Function Class [ Time Frame: Baseline for the first time and after 4 months for the second time ] [ Designated as safety issue: No ]
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).
Same as current
Not Provided
Not Provided
 
Atorvastatin/CoenzymeQ10 in Congestive Heart Failure
Not Provided

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Atorvastatin
  • Drug: Coenzyme Q10
  • Drug: placebo for coenzyme Q10
  • Experimental: Coenzyme Q10 & Atorvastatin
    10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.
    Interventions:
    • Drug: Atorvastatin
    • Drug: Coenzyme Q10
  • Active Comparator: Atorvastatin & placebo
    10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.
    Interventions:
    • Drug: Atorvastatin
    • Drug: placebo for coenzyme Q10
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
Not Provided
January 2014   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact: Amin Nemati, MD 00989131009918 nemati@med.mui.ac.ir
Iran, Islamic Republic of
 
NCT01925937
392219
Not Provided
Amin Nemati, Isfahan University of Medical Sciences
Isfahan University of Medical Sciences
Not Provided
Study Director: Masoud Pourmoghaddas, cardiologist Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Isfahan University of Medical Sciences
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP