The Preventive Efficacy of Carvedilol on Cardiac Dysfunction in Duchenne Muscular Dystrophy

NCT00606775 | Unknown Phase 4 DMC

• 1 other identifier: TN1966220
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Duchenne Muscular Dystrophy; Cardiomyopathies

Keywords

Adrenergic beta-Antagonists; Duchenne Muscular Dystrophy; Cardiomyopathies; Troponin I

Outcome Measures

Primary Outcomes (1)

• The suppression of minor cardiac damage indicated as elevation of plasma cTnI

  2 years

Secondary Outcomes (1)

• Left ventricular function deterioration assessed by echocardiography In-hospital mortality for cardiac dysfunction In-hospital mortality for any cause Overall mortality

  5 years

Study Arms (2)

Carvedilol

EXPERIMENTAL

Drug: Carvedilol

Control

NO INTERVENTION

Interventions

Carvedilol DRUG

2.5-5mg/day

Also known as: Artist, Daich-Sankyo Co.Ltd

Carvedilol

Eligibility Criteria

• Age: 8 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzuka Hospital: lead
• Nagoya University: collaborator

Study Sites (1)

Suzuka Hospial

Suzuka, Mie-ken, 513-8501, Japan

RECRUITING

Related Publications (5)

• Sato Y, Yamada T, Taniguchi R, Nagai K, Makiyama T, Okada H, Kataoka K, Ito H, Matsumori A, Sasayama S, Takatsu Y. Persistently increased serum concentrations of cardiac troponin t in patients with idiopathic dilated cardiomyopathy are predictive of adverse outcomes. Circulation. 2001 Jan 23;103(3):369-74. doi: 10.1161/01.cir.103.3.369.

  PMID: 11157687 BACKGROUND

• Yasuma F, Konagaya M, Sakai M, Kuru S, Kawamura T. A new lease on life for patients with Duchenne muscular dystrophy in Japan. Am J Med. 2004 Sep 1;117(5):363. doi: 10.1016/j.amjmed.2004.03.028. No abstract available.

  PMID: 15336589 BACKGROUND

• Hunsaker RH, Fulkerson PK, Barry FJ, Lewis RP, Leier CV, Unverferth DV. Cardiac function in Duchenne's muscular dystrophy. Results of 10-year follow-up study and noninvasive tests. Am J Med. 1982 Aug;73(2):235-8. doi: 10.1016/0002-9343(82)90184-x.

  PMID: 7114081 BACKGROUND

• Jefferies JL, Eidem BW, Belmont JW, Craigen WJ, Ware SM, Fernbach SD, Neish SR, Smith EO, Towbin JA. Genetic predictors and remodeling of dilated cardiomyopathy in muscular dystrophy. Circulation. 2005 Nov 1;112(18):2799-804. doi: 10.1161/CIRCULATIONAHA.104.528281. Epub 2005 Oct 24.

  PMID: 16246949 BACKGROUND

• Ishikawa Y, Bach JR, Minami R. Cardioprotection for Duchenne's muscular dystrophy. Am Heart J. 1999 May;137(5):895-902. doi: 10.1016/s0002-8703(99)70414-x.

  PMID: 10220639 BACKGROUND

MeSH Terms

Conditions

Muscular Dystrophy, Duchenne; Cardiomyopathies

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Muscular Dystrophies; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Genetic Diseases, X-Linked; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Study Officials

• Takao Nishizawa, MD, PhD

  Department of Cardiology, Nagoya University Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Takao Nishizawa, MD,PhD

CONTACT

+81-52-744-2150; nishizta@med.nagoya-u.ac.jp

Fumihiko Yasuma, MD,PhD

CONTACT

+81-59-378-1321; yasuma@suzuka.go.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: December 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2012
• Last Updated: February 5, 2008

Record last verified: 2007-12

Locations

JP (1)