Phase 4
N=38
Coenzyme Q10 Supplementation in Children With Idiopathic Dilated Cardiomyopathy
Dilated Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT02115581 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Improvement in Left Ventricular Ejection Fraction — 42.1; 37.6 Percentage — p=0.267
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Coenzyme Q10 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult · 0+ yrs
- Sex
- All
- Sponsor
- University of Tehran
- Primary completion
- Mar 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Improvement in Left Ventricular Ejection Fraction |
42.1; 37.6 | 0.267 |
| PRIMARY Improvement in Left Ventricular Filling Abnormality |
59; 19 | 0.011 sig |
| SECONDARY Adverse Events |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02115581). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.