The Preventive Efficacy of Carvedilol on Cardiac Dysfunct... | NCT00606775

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

NCT00606775

Sponsor

Suzuka Hospital

Status

Unknown status

Last Update Posted

Feb 5, 2008Estimated

Enrollment

60Estimated

Phase

Phase 4

Conditions

Duchenne Muscular Dystrophy
Cardiomyopathies

Interventions

Carvedilol

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Dec 2008Estimated

Completion Date

Dec 2012Estimated

First Submitted Date

Jan 22, 2008

First Submission Date that Met QC Criteria

Feb 4, 2008

First Posted Date

Feb 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2008

Last Update Posted Date

Feb 5, 2008Estimated

Name	Class
Nagoya University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carvedilol	Experimental		Drug: Carvedilol
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Carvedilol	Drug	2.5-5mg/day	Carvedilol	Artist, Daich-Sankyo Co.Ltd

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The suppression of minor cardiac damage indicated as elevation of plasma cTnI		2 years

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular function deterioration assessed by echocardiography In-hospital mortality for cardiac dysfunction In-hospital mortality for any cause Overall mortality		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
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

Overall Officials

Name	Affiliation	Role
Takao Nishizawa, MD, PhD	Department of Cardiology, Nagoya University Graduate School of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Suzuka Hospial	Recruiting	Suzuka	Mie-ken	513-8501	Japan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11157687	Background	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.
15336589

ID	Term
D020388	Muscular Dystrophy, Duchenne
D009202	Cardiomyopathies

ID	Term
D009136	Muscular Dystrophies
D020966	Muscular Disorders, Atrophic
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

ID	Term
D011412	Propanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals