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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01904396 |
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Date of registration:
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15/07/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Identification of Carnitine-Responsive Cardiomyopathy
C001 |
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Scientific title:
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Identification of Carnitine-responsive Cardiomyopathy and Myopathy in Adult Patients With Dilated and/or Hypertrophic Cardiomyopathy and Limb Girdle Weakness. |
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Date of first enrolment:
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August 2013 |
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Target sample size:
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30 |
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Recruitment status: |
Not yet recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01904396 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Phase:
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Phase 4
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Countries of recruitment
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Canada
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Contacts
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Name:
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Ingrid Tein, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Hospital for Sick Children, Toronto, Ontario |
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Name:
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Hanna Faghfoury |
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Address:
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Telephone:
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Email:
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hanna.faghfoury@uhn.ca |
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Affiliation:
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Name:
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Faghfoury Hannaneh, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Health Network, Toronto, Ontario |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- An adult patient (>18 years) with a diagnosis of either hypertrophic or dilated
cardiomyopathy, for which the underlying etiology of the cardiomyopathy is unknown.
Exclusion Criteria:
- A history of ischemia
- A documented or suspected infection including HIV
- A history of severe longstanding hypertension
- A history of valvular heart disease
- A history of chemotherapy exposure
- A history of alcohol abuse
- Carnitine supplementation at the time of recruitment
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carnitine Deficiency
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Intervention(s)
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Drug: Carnitine
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Primary Outcome(s)
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Serum Carnitine Concentration
[Time Frame: Baseline]
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Secondary Outcome(s)
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B-Natriuretic Peptide (BNP)
[Time Frame: Baseline, every 6m for up to 2 years]
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Echocardiographic Measures
[Time Frame: Baseline, every 6m for up to 2 years]
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Secondary ID(s)
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Carnitine001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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