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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007033
Receipt No. R000008286
Scientific Title Management of Cardiac Dysfunction Associated With Dystrophinopathy
Date of disclosure of the study information 2012/01/07
Last modified on 2013/02/27

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Basic information
Public title Management of Cardiac Dysfunction Associated With Dystrophinopathy
Acronym MAC-D Study
Scientific Title Management of Cardiac Dysfunction Associated With Dystrophinopathy
Scientific Title:Acronym MAC-D Study
Region
Japan

Condition
Condition cardiac dysfunction associated with dystrophinopathy
Classification by specialty
Cardiology Neurology Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 In cardiac dysfunction associated with dystrophinopathy, we sought to determine whether the clinical outcomes of beta-blockade are related to the administered dose or the degree of heart rate reduction. Moreover, integrated evaluation by serum tenascin C, osteopontin, cTnI, BNP, ECG and echocardiography will be examined.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Clinical composite response
Key secondary outcomes 1) All-cause death
2) Cardiovascular Death
3) All-cause Hospitalization
4) Hospitalization for cardiovascular Disease
5) Hospitalization for heart failure
6) Hospitalization for AMI, ACS, PCI or CABG
7) Cereblar Stroke

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 50 patients with dose-escalation based on tolerability
Interventions/Control_2 50 patients with dose-escalation based on heart rate reduction
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Inclusion criteria are cardiac dysfunction associated with muscular dytrophinopathy, not currently taking carvedilol, and an inpatient or outpatient status.
Male or female patients at any age are required to meet the following criteria:
Left ventricular ejection fraction 50% or less, based on echocardiography.
Chronic or transient atrial fibrillation, non-sustained ventricular tachycardia or severe premature ventricular contraction.
Progressing cardiac dysfunction, aggravated arrhythmias or heart failure
The patient must give written informed consent prior to enrolment into this study.
Key exclusion criteria Patients with the following conditions were excluded: valvular heart disease, hypertrophic obstructive, restrictive, arrhythmogenic right ventricular or advanced inflammatory cardiomyopathy, cardiogenic shock, systolic blood pressure under (80 mm Hg or less at rest, supine), bradycardia (50 orless/min at rest), grade II or III atrioventricular block, life-threatening arrhythmia, and unstable angina, and resting angina. Patients were also excluded if myocardial infarction, coronary artery bypass grafting or percutaneous coronary intervention had occurred within the preceding 3 months and cerebral stroke (transient ischemia, infarction, hemorrhage) had occurred within the preceding 6 months. Severe asthma or other chronic obstructive pulmonary disease and pulmonale. Patients with past history of malignancy or other life threatening diseases diagnosed within 5 years before informed consent. Arteriosclerosis obliterans1 (>Fontaine degree II) Severe anemia (Hb:6.0mg or less/dL). Uncontrolled diabetes mellitus. Significant renal impairment defined as a creatinine value 3.0mg/dL or more. Significant hepatic impairment defined as ALT or AST value 100 or more. Uncontrolled thyroid function disorder. Pregnancy. Allergy or known hypersensitivity to beta blockade. Significant disease, which in the investigator's opinion would exclude the patient from the study.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Okamoto
Organization National Hospital Organization Hokkaido Medical Center
Division name Department of Cardiovascular Medicine
Zip code
Address Yamanote 5-7, Nishi-ku, Sapporo 063-0005, Japan
TEL +81-11-611-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Okamoto
Organization National Hospital Organization Hokkaido Medical Center
Division name Department of Cardiovascular Medicine
Zip code
Address Yamanote 5-7, Nishi-ku, Sapporo 063-0005, Japan
TEL +81-11-611-8111
Homepage URL http://poppy.ac/mac-d/
Email okamotoh@hok-mc.hosp.go.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2011 Year 11 Month 04 Day
Date of IRB
Anticipated trial start date
2012 Year 01 Month 01 Day
Last follow-up date
2014 Year 02 Month 01 Day
Date of closure to data entry
2014 Year 02 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 01 Month 07 Day
Last modified on
2013 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008286

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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