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Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

Primary Purpose

Congestive Heart Failure

Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Atorvastatin
Coenzyme Q10
placebo for coenzyme Q10
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congestive Heart Failure focused on measuring Coenzyme Q10, Atorvastatin, clinical trial, congestive heart failure

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, IranRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Coenzyme Q10 & Atorvastatin

Atorvastatin & placebo

Arm Description

10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.

10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

Full Information

First Posted
August 8, 2013
Last Updated
August 16, 2013
Sponsor
Isfahan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01925937
Brief Title
Atorvastatin/CoenzymeQ10 in Congestive Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
January 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Coenzyme Q10, Atorvastatin, clinical trial, congestive heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coenzyme Q10 & Atorvastatin
Arm Type
Experimental
Arm Description
10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.
Arm Title
Atorvastatin & placebo
Arm Type
Active Comparator
Arm Description
10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Type
Drug
Intervention Name(s)
Coenzyme Q10
Intervention Type
Drug
Intervention Name(s)
placebo for coenzyme Q10
Primary Outcome Measure Information:
Title
Change in cardiac Ejection Fraction (EF)
Description
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).
Time Frame
Baseline for the first time and after 4 months for the second time
Secondary Outcome Measure Information:
Title
Change in New York Heart Association Function Class
Description
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).
Time Frame
Baseline for the first time and after 4 months for the second time

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amin Nemati, MD
Phone
00989131009918
Email
nemati@med.mui.ac.ir
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masoud Pourmoghaddas, cardiologist
Organizational Affiliation
Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Official's Role
Study Director
Facility Information:
Facility Name
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
ZIP/Postal Code
8174673461
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amin Nemati, MD
Phone
00989131009918
Email
nemati@med.mui.ac.ir
First Name & Middle Initial & Last Name & Degree
Javad Shahabi, MD

12. IPD Sharing Statement

Learn more about this trial

Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

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