A Phase 4 interventional study of Carvedilol in Duchenne Muscular Dystrophy and Cardiomyopathies, sponsored by Suzuka Hospital. Status unknown at 1 site in Japan. Open to male participants aged 8 Years to 45 Years. Per ClinicalTrials.gov, last updated 2008-02-05.
Sponsored by Suzuka Hospital · Phase 4, Interventional, and Prevention
Purpose This cardiac dysfunction in patients with Duchenne muscular dystrophy is associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). The purpose of this study is to investigate whether the administration of Carvedilol can suppress the minor cardiac damage and prevent deterioration of cardiac function.
The life span in patients with Duchenne muscular dystrophy has been extending due to the development of artificial respiratory devices. According to that, the ratio of cardiac dysfunction as a cause of death has been increasing. This cardiac dysfunction was associated with minor cardiac damage as indicated by elevation of plasma cardiac troponin I (cTnI). Furthermore, and the detection rate of cTnI plasma as revealed to be correlated with the deterioration speed of LV dysfunction assessed by serial echocardiography measurements. Accordingly, if this minor cardiac damage is suppressed, it is postulated that the progression of cardiac dysfunction can be stopped. In the cases with ventricular arrhythmia and tachycardia, we found plasma cTnI became undetectable after administration of beta-blocker. Accordingly, we investigate whether administration of beta-blocker, carvedilol can persistently suppress the minor cardiac damage and lead to suppress the deterioration of LV function. Note that his study preventive study for preserved to moderate LV dysfunction and is not intended to the beta-blocker treatment for severe LV dysfunction. Because we assume that the mechanism of elevation of cTnI is different; spontaneous in preserved to mild LV dysfunction in patients but LV wall stress in severe LV dysfunction in patients with Duchenne muscular dystrophy.
548 studies on the registry are indexed under Muscular Dystrophies; 89 are open to participants now.
This study's planned enrollment of 60 is above the median of 24 across 344 interventional studies indexed under Muscular Dystrophies.
Browse Muscular Dystrophies studies →This is the only study on the registry with Suzuka Hospital as lead sponsor.
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Male patients with Duchenne muscular dystrophy are required to meet the following criteria:
Exclusion Criteria:
Patients with the following conditions will be excluded from the study:
Drug: Carvedilol
2.5-5mg/day
Also known as: Artist, Daich-Sankyo Co.Ltd
The suppression of minor cardiac damage indicated as elevation of plasma cTnI
Time frame: 2 years
Left ventricular function deterioration assessed by echocardiography In-hospital mortality for cardiac dysfunction In-hospital mortality for any cause Overall mortality
Time frame: 5 years
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