Atorvastatin/CoenzymeQ10 in Congestive Heart Failure

NCT ID: NCT01925937

Last Updated: 2013-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure

Keywords

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Coenzyme Q10 Atorvastatin clinical trial congestive heart failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Coenzyme Q10 & Atorvastatin

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

Group Type EXPERIMENTAL

Atorvastatin

Intervention Type DRUG

Coenzyme Q10

Intervention Type DRUG

Atorvastatin & placebo

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

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

placebo for coenzyme Q10

Intervention Type DRUG

Interventions

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Atorvastatin

Intervention Type DRUG

Coenzyme Q10

Intervention Type DRUG

placebo for coenzyme Q10

Intervention Type DRUG

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Amin Nemati

member of Isfahan Medical Students Research Committee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Masoud Pourmoghaddas, cardiologist

Role: STUDY_DIRECTOR

Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.

Locations

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Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran

Isfahan, Isfahan, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Amin Nemati, MD

Role: CONTACT

Phone: 00989131009918

Email: [email protected]

Facility Contacts

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Amin Nemati, MD

Role: primary

Other Identifiers

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392219

Identifier Type: -

Identifier Source: org_study_id