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| Sponsor: | Suzuka Hospital |
|---|---|
| Collaborator: |
Nagoya University |
| Information provided by: | Suzuka Hospital |
| ClinicalTrials.gov Identifier: | NCT00606775 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Duchenne Muscular Dystrophy Cardiomyopathies |
Drug: Carvedilol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy |
| Estimated Enrollment: | 60 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Carvedilol: Experimental |
Drug: Carvedilol
2.5-5mg/day
|
| Control: No Intervention |
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.
Eligibility| Ages Eligible for Study: | 8 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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:
Contacts and Locations| Contact: Takao Nishizawa, MD,PhD | +81-52-744-2150 | nishizta@med.nagoya-u.ac.jp |
| Contact: Fumihiko Yasuma, MD,PhD | +81-59-378-1321 | yasuma@suzuka.go.jp |
| Japan, Mie | |
| Suzuka Hospial | Recruiting |
| Suzuka, Mie, Japan, 513-8501 | |
| Contact: Takao Nishizawa, MD. PhD +81-52-744-2150 nishizta@med.nagoya-u.ac.jp | |
| Contact: Fumihiko Yasuma, MD. PhD +81-593-78-0337 yasuma@suzuka.go.jp | |
| Sub-Investigator: Fumihiko Yasuma, MD, PhD | |
| Sub-Investigator: Toshimitsu Mori, MD | |
| Sub-Investigator: Motoko Sakai, MD, PhD | |
| Sub-Investigator: Satoshi Kuru, MD, PhD | |
| Sub-Investigator: Seigo Kimura, MD | |
| Sub-Investigator: Takuya Tamura, MD | |
| Sub-Investigator: Kentaro Sahashi, MD | |
| Sub-Investigator: Rei Shibata, MD, PhD | |
| Sub-Investigator: Taiki Ohashi, MD | |
| Principal Investigator: | Takao Nishizawa, MD, PhD | Department of Cardiology, Nagoya University Graduate School of Medicine |
More Information
| Responsible Party: | Department of Cardiology, Nagoya Universtiy Graduate School of Medicine ( Takao Nishizawa ) |
| Study ID Numbers: | TN1966220 |
| Study First Received: | January 22, 2008 |
| Last Updated: | February 4, 2008 |
| ClinicalTrials.gov Identifier: | NCT00606775 History of Changes |
| Health Authority: | Japan: Institutional Review Board |
|
Adrenergic beta-Antagonists Duchenne Muscular Dystrophy Cardiomyopathies Troponin I |
|
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Neuromuscular Diseases Musculoskeletal Diseases Muscular Disorders, Atrophic Therapeutic Uses Genetic Diseases, X-Linked Adrenergic beta-Antagonists Cardiovascular Diseases Carvedilol |
Heart Diseases Nervous System Diseases Cardiovascular Agents Adrenergic alpha-Antagonists Antihypertensive Agents Cardiomyopathies Pharmacologic Actions Muscular Dystrophies Muscular Diseases Genetic Diseases, Inborn Muscular Dystrophy, Duchenne Adrenergic Antagonists |