Atorvastatin/CoenzymeQ10 in Congestive Heart Failure
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 8, 2013
CompletedFirst Posted
Study publicly available on registry
August 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedAugust 20, 2013
August 1, 2013
7 months
August 8, 2013
August 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline for the first time and after 4 months for the second time
Secondary Outcomes (1)
Change in New York Heart Association Function Class
Baseline for the first time and after 4 months for the second time
Study Arms (2)
Coenzyme Q10 & Atorvastatin
EXPERIMENTAL10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months.
Atorvastatin & placebo
ACTIVE COMPARATOR10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan, Isfahan, 8174673461, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Masoud Pourmoghaddas, cardiologist
Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- member of Isfahan Medical Students Research Committee
Study Record Dates
First Submitted
August 8, 2013
First Posted
August 20, 2013
Study Start
June 1, 2013
Primary Completion
January 1, 2014
Last Updated
August 20, 2013
Record last verified: 2013-08