UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007033 |
|---|---|
| Receipt number | 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 13:23:22 |
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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
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/
okamotoh@hok-mc.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008286
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| Registered date | File name |
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| Registered date | File name |
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