Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

August 16, 2013 updated by: Amin Nemati, Isfahan University of Medical Sciences
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Isfahan, Iran, Islamic Republic of, 8174673461
        • Recruiting
        • Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
        • Contact:
        • Principal Investigator:
          • Javad Shahabi, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in cardiac Ejection Fraction (EF)
Time Frame: Baseline for the first time and after 4 months for the second time
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in New York Heart Association Function Class
Time Frame: Baseline for the first time and after 4 months for the second time
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Isfahan University of Medical Sciences

Investigators

  • Study Director: Masoud Pourmoghaddas, cardiologist, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

January 1, 2014

Study Registration Dates

First Submitted

August 8, 2013

First Submitted That Met QC Criteria

August 16, 2013

First Posted (Estimate)

August 20, 2013

Study Record Updates

Last Update Posted (Estimate)

August 20, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 392219

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Congestive Heart Failure

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in India

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe