Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Drug: Atorvastatin
Drug: Coenzyme Q10
Drug: placebo for coenzyme Q10

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Isfahan University of Medical Sciences:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 30
Study Start Date: June 2013
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Coenzyme Q10 & Atorvastatin
10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.
Drug: Atorvastatin Drug: Coenzyme Q10
Active Comparator: Atorvastatin & placebo
10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.
Drug: Atorvastatin Drug: placebo for coenzyme Q10

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01925937

Contacts
Contact: Amin Nemati, MD 00989131009918 nemati@med.mui.ac.ir

Locations
Iran, Islamic Republic of
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran Recruiting
Isfahan, Iran, Islamic Republic of, 8174673461
Contact: Amin Nemati, MD    00989131009918    nemati@med.mui.ac.ir   
Principal Investigator: Javad Shahabi, MD         
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
Study Director: Masoud Pourmoghaddas, cardiologist Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
  More Information

No publications provided

Responsible Party: Amin Nemati, member of Isfahan Medical Students Research Committee, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01925937     History of Changes
Other Study ID Numbers: 392219
Study First Received: August 8, 2013
Last Updated: August 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Isfahan University of Medical Sciences:
Coenzyme Q10
Atorvastatin
clinical trial
congestive heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Coenzyme Q10
Ubiquinone
Atorvastatin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014