Pediatric Dilated Cardiomyopathy Clinical Trial
| Verified date | July 2018 |
| Source | Chung Shan Medical University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme Q10 supplements to evaluate their potential role as complementary therapy for PDCM. The purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the quality of life of PDCM patients by questionnaire. Through this study, we expect to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in PDCM.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | July 6, 2018 |
| Est. primary completion date | May 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Month to 20 Years |
| Eligibility |
Inclusion Criteria: - Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction = 40 % by cardiac echo examination. Exclusion Criteria: - Hypertension - Arrhythmia - Congenital heart defects - Acute myocarditis - Pregnant and lactating teens - Antioxidant vitamins users |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | Chung Shan Medical University | Taichung |
| Lead Sponsor | Collaborator |
|---|---|
| Chung Shan Medical University |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Left ventricular ejection fraction | Left ventricular ejection fraction (%) will be measured by cardiac echo. | 6 months | |
| Secondary | Levels of plasma coenzyme Q10 | Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography. | 6 months | |
| Secondary | B-type natriuretic peptide (BNP) | BNP (pg/mL) will be measured by fluorescence immunoassay. | 6 months | |
| Secondary | malondialdehyde (MDA) | MDA (micromol/L) will be measured by thiobarbituric acid reacting substance. | 6 months | |
| Secondary | catalase (CAT) | red blood cells level of CAT in unit/mg protein. | 6 months | |
| Secondary | glutathione peroxide (GPx) | red blood cells level of GPx in unit/mg protein. | 6 months | |
| Secondary | superoxide dismutase (SOD) | red blood cells level of SOD in unit/mg protein. | 6 months | |
| Secondary | high sensitivity C-reactive protein (hs-CRP) | hs-CRP (mg/dL) will be measured by Immunoturbidimetry. | 6 months | |
| Secondary | high sensitivity interleukin-6 (IL-6) | IL-6 (pg/dL) will be measured by immunosorbent assay. | 6 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT03214757 -
A Study of Impact of Anemia on Morbidity and Mortality in Children With Dilated Cardiomyopathy
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N/A |