NCT02115581

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2008

Completed
5.3 years until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
Same day until next milestone

Results Posted

Study results publicly available

April 16, 2014

Completed
Last Updated

April 16, 2014

Status Verified

March 1, 2014

Enrollment Period

1.5 years

First QC Date

December 22, 2008

Results QC Date

December 22, 2008

Last Update Submit

March 14, 2014

Conditions

Dilated Cardiomyopathy

Keywords

Coenzyme O10ChildrenIdiopathic Dilated Cardiomyopathy

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    6 months

Secondary Outcomes (1)

  • Adverse Events

    6 months

Study Arms (2)

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.

Drug: Coenzyme Q10

Placebo

PLACEBO COMPARATOR

known cases of idiopathic dilated cardiomyopathy who received placebo

Drug: Placebo

Interventions

Coenzyme Q10DRUG

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

Also known as: Ubiquinone
Coenzyme Q10
PlaceboDRUG

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

Also known as: no brand name
Placebo

Eligibility Criteria

Age6 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Medical Center

Tehran, Tehran Province, 14194, Iran

Location

MeSH Terms

Conditions

Cardiomyopathy, Dilated

Interventions

coenzyme Q10Ubiquinone

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesCardiomyopathiesLaminopathiesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and Coenzymes

Results Point of Contact

Title
Giv Heidari-Bateni MD/MPH
Organization
Children's Medical Center
givhb@yahoo.com
3142991984

Study Officials

  • Reza Shabanian, MD

    Children's Medical Center

    STUDY DIRECTOR

  • Armen Kocharian, MD

    Children's Medical Center

    STUDY CHAIR

  • Giv Heidari-Bateni, MD/MPH

    Children's Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

December 22, 2008

First Posted

April 16, 2014

Study Start

September 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 16, 2014

Results First Posted

April 16, 2014

Record last verified: 2014-03

Locations

IR(1)