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Trial record 4 of 157 for:    Idiopathic Dilated Cardiomyopathy

Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02115581
Recruitment Status : Completed
First Posted : April 16, 2014
Results First Posted : April 16, 2014
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Giv Heidari-Bateni, University of Tehran

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dilated Cardiomyopathy
Interventions Drug: Coenzyme Q10
Drug: Placebo
Enrollment 38
Recruitment Details Patients younger than 18 years with known diagnosis of primary dilated cardiomyopathy referred for follow-up echocardiography to Children’s Medical Center between September 2006 to March 2008 were recruited.
Pre-assignment Details  
Arm/Group Title Coenzyme Q10 Placebo
Hide Arm/Group Description Known cases of idiopathic dilated cardiomyopathy who received Co Q10 Known cases of idiopathic dilated cardiomyopathy who received the placebo
Period Title: Overall Study
Started 17 21
Completed 17 21
Not Completed 0 0
Arm/Group Title Conezyme Q10 Placebo Total
Hide Arm/Group Description known cases of idiopathic dilated cardiomyopathy who received Co Q10 known cases of idiopathic dilated cardiomyopathy who received the placebo Total of all reporting groups
Overall Number of Baseline Participants 17 21 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 21 participants 38 participants
6.3  (4.5) 7.3  (5.2) 6.9  (5.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 21 participants 38 participants
Female
9
  52.9%
10
  47.6%
19
  50.0%
Male
8
  47.1%
11
  52.4%
19
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iran, Islamic Republic of Number Analyzed 17 participants 21 participants 38 participants
17 21 38
1.Primary Outcome
Title Improvement in Left Ventricular Ejection Fraction
Hide Description Ejection Fraction of left ventricle (percentage of blood pumped out of left ventricle with each heart beat) calculated by echocardiography
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conezyme Q10 Placebo
Hide Arm/Group Description:
Known cases of idiopathic dilated cardiomyopathy who received Co Q10
Known cases of idiopathic dilated cardiomyopathy who received the placebo
Overall Number of Participants Analyzed 17 21
Mean (Standard Deviation)
Unit of Measure: Percentage
42.1  (14.7) 37.6  (9.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conezyme Q10, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.267
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Improvement in Left Ventricular Filling Abnormality
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conezyme Q10 Placebo
Hide Arm/Group Description:
Known cases of idiopathic dilated cardiomyopathy who received Co Q10
Known cases of idiopathic dilated cardiomyopathy who received the placebo
Overall Number of Participants Analyzed 17 21
Measure Type: Number
Unit of Measure: Percentage
59 19
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Conezyme Q10, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Adverse Events
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Conezyme Q10 Placebo
Hide Arm/Group Description:
Known cases of idiopathic dilated cardiomyopathy who received Co Q10
Known cases of idiopathic dilated cardiomyopathy who received the placebo
Overall Number of Participants Analyzed 17 21
Measure Type: Number
Unit of Measure: Participants
0 0
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Coenzyme Q10 (Study Group) Placebo (Control Group)
Hide Arm/Group Description

Known cases of idiopathic dilated cardiomyopathy

Coenzyme Q10: 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

Known cases of idiopathic dilated cardiomyopathy

Placebo: 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

All-Cause Mortality
Coenzyme Q10 (Study Group) Placebo (Control Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Coenzyme Q10 (Study Group) Placebo (Control Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Coenzyme Q10 (Study Group) Placebo (Control Group)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Giv Heidari-Bateni MD/MPH
Organization: Children's Medical Center
Phone: 3142991984
EMail: givhb@yahoo.com
Layout table for additonal information
Responsible Party: Giv Heidari-Bateni, University of Tehran
ClinicalTrials.gov Identifier: NCT02115581     History of Changes
Other Study ID Numbers: CoenzymeQ10 and Cardiomyopathy
First Submitted: December 22, 2008
First Posted: April 16, 2014
Results First Submitted: December 22, 2008
Results First Posted: April 16, 2014
Last Update Posted: April 16, 2014