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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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EUCTR |
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Last refreshed on:
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2 October 2017 |
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Main ID: |
EUCTR2006-003075-12-IE |
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Date of registration:
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13/07/2006 |
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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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Effect of carvedilol on left ventricular systolic and diastolic function and the neurohormonal axis in patients with Duchenne muscular dystrophy and left ventricular dysfunction.
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Scientific title:
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Effect of carvedilol on left ventricular systolic and diastolic function and the neurohormonal axis in patients with Duchenne muscular dystrophy and left ventricular dysfunction.
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Date of first enrolment:
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Target sample size:
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30 |
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Recruitment status: |
NA |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-003075-12 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Ireland
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1.Diagnosis of confirmed DMD with either dilated LV (>2Z scores) and depressed LV systolic function (LVEF <40%).
2.Agreement to participate.
3.Patients already treated with afterload reduction (ACE inhibitors), digitalis or diuretics will not be excluded as they will act as their own controls in determining positive or negative effects of carvedilol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1.Refusal to participate.
2.Severe asthma which would be exacerbated by beta-blockade
3.Glucose intolerance or diabetes mellitus.
4.Severe claustrophobia which would prevent MR.
5.Any major contra-indication to cardiac MRI
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Duchenne muscular dystrophy is an X-linked inherited disorder which primarily affects skeletal muscle through a mutation in dystrophin which maps to the long arm of the X chromosome (Xp21). Patients with skeletal myopathy such as DMD eventually progress to develop dilated cardiomyopathy as dystrophin is expressed in all forms of muscle including cardiac and smooth muscle. Often the cause of death in patients with DMD is cardiac failure and arrhythmia.
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Intervention(s)
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Trade Name: Eucardic
Product Name: Eucardic
Product Code: No code
Pharmaceutical Form: Tablet
INN or Proposed INN: CARVEDILOL
CAS Number: 72956093
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 3.125mg-6.25mg
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Primary Outcome(s)
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Main Objective: 1.Determine baseline left ventricular systolic function using cardiac MRI, neurohormonal status (B natriuretic peptide levels, secreted by ventricular myocardium in congestive heart failure), two-dimensional echocardiographic and tissue Doppler imaging characteristics of a cohort of patients (children / adolescents 7-18 years age) with DMD.
2.Determine the effects of carvedilol on LV ejection fraction, LV end-diastolic and systolic volumes, BNP levels, and tissue Doppler imaging velocities. The effects on these parameters (LV dimensions, LVEF, tissue Doppler velocities) will be measured at baseline and at 6 months after commencing therapy. The effects on BNP levels will be assessed at baseline, 1 and 6 months after initiation of therapy.
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Primary end point(s): 1. Left ventricular ejection fraction.
2. Left ventricular shortening fraction.
3. Left ventricular end diastolic and systolic volumes.
4. Tissue Doppler velocities.
5. BNP levels.
6. Clinical improvement of symptoms (NYHA status) and signs of heart failure.
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Secondary Objective:
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Source(s) of Monetary Support
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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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