The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy
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ClinicalTrials.gov Identifier: NCT00606775 |
Recruitment Status : Unknown
Verified December 2007 by Suzuka Hospital.
Recruitment status was: Recruiting
First Posted : February 5, 2008
Last Update Posted : February 5, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Duchenne Muscular Dystrophy Cardiomyopathies | Drug: Carvedilol | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Carvedilol for the Prevention of Minor Cardiac Damage and Cardiac Function in Duchenne Muscular Dystrophy |
Study Start Date : | December 2007 |
Estimated Primary Completion Date : | December 2008 |
Estimated Study Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Carvedilol |
Drug: Carvedilol
2.5-5mg/day
Other Name: Artist, Daich-Sankyo Co.Ltd |
No Intervention: Control |
- 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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Ages Eligible for Study: | 8 Years to 45 Years (Child, Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Male patients with Duchenne muscular dystrophy are required to meet the following criteria:
- Aged 8 to 45 years
- Positive plasma cardiac troponin I (0.06ng/mL) at least 4 blood measurement in every 3 month.
- Left ventricular ejection fraction >30% by echocardiography assessment
- Written informed consent
Exclusion Criteria:
Patients with the following conditions will be excluded from the study:
- Left ventricular ejection fraction <30%
- No plasma cTnI elevation
- beta-blocker is already administered without measurement of plasma cTnI
- Contraindication against treatment with β blockers
- Any other serious disease that could potentially complicate the management and follow-up protocols

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606775
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 | |
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 |
Responsible Party: | Takao Nishizawa, Department of Cardiology, Nagoya Universtiy Graduate School of Medicine |
ClinicalTrials.gov Identifier: | NCT00606775 |
Other Study ID Numbers: |
TN1966220 |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | February 5, 2008 |
Last Verified: | December 2007 |
Adrenergic beta-Antagonists Duchenne Muscular Dystrophy Cardiomyopathies Troponin I |
Muscular Dystrophies Muscular Dystrophy, Duchenne Cardiomyopathies Heart Diseases Cardiovascular Diseases Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, Inborn Genetic Diseases, X-Linked Carvedilol Adrenergic beta-Antagonists |
Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antihypertensive Agents Antioxidants Protective Agents Calcium Channel Blockers Membrane Transport Modulators Calcium-Regulating Hormones and Agents Vasodilator Agents Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists |