Determination of the effect of coenzyme Q10 on echocardiographic parameters in children with dilated cardiomyopathy
Design
In this one-arm trial study, a complete history of the patient will be included and the variables of age, sex, weight, duration of disease, cause of failure and possible complications of coenzyme Q10 will be obtained from the patients. Patients then will be underwent cardiac echocardiography and the variables of Ejection fraction (volume of blood pumped by the heart per beat), fractional shortening (fraction of diastolic dimensional loss lost in systolic systole), and aortic valve regurgitation will be recorded. Patients will then be treated with coenzyme Q10 at a dose of 1 mg (Golden Life, Australia) per kg/day orally for 2 months. Patients dissolve the drug in water and take it orally. After 2 months, the patients will be re-examined and the desired variables will be re-examined and possible side effects of the drug were recorded. During the treatment, the patient will contacted every 4 weeks for continuous use of the drug and the patient was also asked to deliver the package of drugs used.
Settings and conduct
This study is a one-arm clinical trial that was performed on children with heart failure due to dilated cardiomyopathy who were referred to Bandar Abbas Children's Hospital in 1398 and 1399. Sampling was done by availability and continued until the desired sample size was met.
Participants/Inclusion and exclusion criteria
Inclusion criteria were considered children with heart failure due to dilated cardiomyopathy. Exclusion criteria were considered to be metabolic diseases or other comorbidities that affect the cardiac variables studied in this study.
Intervention groups
Patients then treated with coenzyme Q10 1 mg (Golden Life, Australia) per kilogram per day for 2 months orally.
Main outcome variables
Echocardiographic parameters including EF, FS, MR, TR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190612043878N1
Registration date:2021-04-14, 1400/01/25
Registration timing:retrospective
Last update:2021-04-14, 1400/01/25
Update count:0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Ehsan Zarepur
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3624 5341
Email address
ehsanzarepur@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-22, 1399/06/01
Expected recruitment end date
2021-03-21, 1400/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Coenzyme Q10 on echocardiographic parameters in patients with heart failure due to dilated cardiomyopathy
Public title
Effect of Coenzyme Q10 on echocardiographic parameters
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with heart failure due to dilated cardiomyopathy
Exclusion criteria:
Metabolic diseases
Other cardiac diseases
Age
To 15 years old
Gender
Both
Phase
0
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hormozgan Ubiversity of medical Sciences ethics committee
Street address
Hormozgan Ubiversity of medical Sciences, Shahid Chamran St., Bandar Abbas
City
Bandar Abbas
Province
Hormozgan
Postal code
7916839319
Approval date
2019-12-24, 1398/10/03
Ethics committee reference number
IR.HUMS.REC.1398.350
Health conditions studied
1
Description of health condition studied
Congestive Heart Failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Ejection fraction
Timepoint
2 months
Method of measurement
Echocardiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will be treated with coenzyme Q10 1 mg (Golden Life, Australia), orally daily for 2 months.