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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014