Dilated CardiomyopathyPhase 4NCT02115581
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
A Phase 4 study testing Coenzyme Q10 in people with Dilated Cardiomyopathy, run by University of Tehran at 1 site in Iran.
Trial summary
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Coenzyme Q10
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteIran
- Study dates
- Sep 2006to Mar 2008
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Known cases of Idiopathic Dilated Cardiomyopathy (IDC)
- Those patients in whom heart failure medications were stable for at least 1 month
- More than 6 months aged
Who cannot join
- Recent modification in medications
- Hemodynamic instability
- Congenital heart disease
- Metabolic heart disease
- Cardiac dysfunction resulting from abnormalities in other organs and those with an acquired cardiomyopathy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Coenzyme Q10 (Ubiquinone) Supplementation on Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy.A Randomised Clinical Trial
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.
Read the detailed description
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomizes to receive either Coenzyme Q10 or placebo. Echocardiographic systolic and diastolic function parameters are determined for every patient at baseline, after three,six and nine months of supplementation.
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Coenzyme Q10, Placebo
- Keywords
- Coenzyme O10, Children, Idiopathic Dilated Cardiomyopathy
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coenzyme Q10Drug
Also called Ubiquinone
dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
PlaceboDrug
Also called no brand name
dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
| Study group | Role | What they receive |
|---|---|---|
| Coenzyme Q10 | Experimental | Known cases of idiopathic dilated cardiomyopathy who received supplementation of coenzyme Q10 as a part of their medical regimen.
Dosage administered: 2 milligram/kilogram/day in 2 or 3 divided doses, these being increased to the maximum dose of 10 milligram/kilogram/day according to tolerance or the appearance of sideeffects. Receives: Drug: Coenzyme Q10 |
| Placebo | Placebo comparator | known cases of idiopathic dilated cardiomyopathy who received placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Left Ventricular Ejection Fraction
Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography
Measured: 6 months
Improvement in Left Ventricular Filling Abnormality
Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.
Measured: 6 months
Secondary outcomes (1)
Adverse Events
Number of patients with evidence of adverse reaction to coenzyme Q10 including nausea, vomiting, changes in blood pressure, neurological signs or any abnormal behavior like disquiet in young children.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startSep 2006
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dilated CardiomyopathyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tehran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giv Heidari-Bateni, University of Tehran
- Investigators
- Reza Shabanian, MD, Study director, Children's Medical CenterArmen Kocharian, MD, Study chair, Children's Medical CenterGiv Heidari-Bateni, MD/MPH, Principal investigator, Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115581
- Sponsor's protocol ID
- CoenzymeQ10 and Cardiomyopathy
- Status last verified
- Mar 2014
- First submitted
- 22 Dec 2008
- Last updated
- 16 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Coenzyme Q10 (Ubiquinone) Supplementation on Ventricular Function of Children With Idiopathic Dilated Cardiomyopathy.A Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT02115581
- Acronym / sponsor ID
- CoenzymeQ10 and Cardiomyopathy
- Conditions
- Dilated Cardiomyopathy
- Keywords
- Coenzyme O10, Children, Idiopathic Dilated Cardiomyopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of TehranUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Posted 16 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.
Detailed description
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomizes to receive either Coenzyme Q10 or placebo. Echocardiographic systolic and diastolic function parameters are determined for every patient at baseline, after three,six and nine months of supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coenzyme Q10 | Experimental | Drug: Coenzyme Q10Known cases of idiopathic dilated cardiomyopathy who received supplementation of coenzyme Q10 as a part of their medical regimen. Dosage administered: 2 milligram/kilogram/day in 2 or 3 divided doses, these being increased to the maximum dose of 10 milligram/kilogram/day according to tolerance or the appearance of sideeffects. |
| Placebo | Placebo comparator | Drug: Placeboknown cases of idiopathic dilated cardiomyopathy who received placebo |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Known cases of Idiopathic Dilated Cardiomyopathy (IDC)
- Those patients in whom heart failure medications were stable for at least 1 month
- More than 6 months aged
Key exclusion criteria (5 listed)
- Recent modification in medications
- Hemodynamic instability
- Congenital heart disease
- Metabolic heart disease
- Cardiac dysfunction resulting from abnormalities in other organs and those with an acquired cardiomyopathy
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 |
|---|---|---|
| Coenzyme Q10Also: Ubiquinonedose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance | Drug | Coenzyme Q10 |
| PlaceboAlso: no brand namedose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance | Drug | Placebo |
Primary outcome
Improvement in Left Ventricular Ejection Fraction
Time frame: 6 months
Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography
Improvement in Left Ventricular Filling Abnormality
Time frame: 6 months
Doppler-derived transmitral blood flow and pulmonary venous blood flow data were used for grading of the severity of diastolic filling abnormality in patients before and after the intervention. Diastolic filling abnormality was categorized as: 1- normal 2- abnormal relaxation 3- pseudonormal 4- restricted pattern based on echo data. The proportion of patients who showed improvement in the diastolic function grading was compared between the study groups.
1 secondary outcome
Adverse Events
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Reza Shabanian, MD study director
Children's Medical Center
Armen Kocharian, MD study chair
Children's Medical Center
Giv Heidari-Bateni, MD/MPH principal investigator
Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Coenzyme Q10 in people with Dilated Cardiomyopathy, run by University of Tehran 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Apr 2014. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Left Ventricular Ejection Fraction (time frame: 6 months). The study lists 2 primary outcomes in all. 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 16 Apr 2014.