Congestive Heart FailureNCT01925937
Atorvastatin/CoenzymeQ10 in Congestive Heart Failure
A study testing Atorvastatin and Coenzyme Q10 in people with Congestive Heart Failure, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Atorvastatin and Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Jun 2013to Jan 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Vice Chancellery for Research of Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan, Isfahan, 8174673461
Amin Nemati, MD, 00989131009918, nemati@med.mui.ac.ir
Javad Shahabi, MD
About this study
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.
- Conditions
- Congestive Heart Failure
- Being tested
- Atorvastatin, Coenzyme Q10, placebo for coenzyme Q10
- Keywords
- Coenzyme Q10, Atorvastatin, clinical trial, congestive heart failure
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Coenzyme Q10Drug
placebo for coenzyme Q10Drug
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 & Atorvastatin | Experimental | 10 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months. Receives: Drug: Atorvastatin; Drug: Coenzyme Q10 |
| Atorvastatin & placebo | Active comparator | 10 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months. Receives: Drug: Atorvastatin; Drug: placebo for coenzyme Q10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline for the first time and after 4 months for the second time
Secondary outcomes (1)
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).
Measured: Baseline for the first time and after 4 months for the second time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2013 (estimated)
- Study startJun 2013
- Primary completionJan 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin Nemati, Isfahan University of Medical Sciences
- Investigators
- Masoud Pourmoghaddas, cardiologist, Study director, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01925937
- Sponsor's protocol ID
- 392219
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2013
- Last updated
- 20 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin/CoenzymeQ10 in Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT01925937
- Acronym / sponsor ID
- 392219
- Conditions
- Congestive Heart Failure
- Keywords
- Coenzyme Q10, Atorvastatin, clinical trial, congestive heart failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 20 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 & Atorvastatin | Experimental | Drug: Atorvastatin, Drug: Coenzyme Q1010 mg Atorvastatin daily plus 100 mg Coenzyme Q10 pearl supplement twice daily for four months. |
| Atorvastatin & placebo | Active comparator | Drug: Atorvastatin, Drug: placebo for coenzyme Q1010 mg Atorvastatin daily and the placebo of Coenzyme Q10 pearl for four months. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Acute coronary syndrome developing in the last month
- Active myocarditis
- Active pericarditis
- Uncontrolled hypertension
- Hepatic failure(Child B,C)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | Atorvastatin & placebo, Coenzyme Q10 & Atorvastatin |
| Coenzyme Q10 | Drug | Coenzyme Q10 & Atorvastatin |
| placebo for coenzyme Q10 | Drug | Atorvastatin & placebo |
Primary outcome
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).
1 secondary outcome
Change in New York Heart Association Function Class
Time frame: Baseline for the first time and after 4 months for the second time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Masoud Pourmoghaddas, cardiologist study director
Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atorvastatin and Coenzyme Q10 in people with Congestive Heart Failure, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amin Nemati, MD (00989131009918, nemati@med.mui.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cardiac Ejection Fraction (EF) (time frame: Baseline for the first time and after 4 months for the second time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2013.