Management of Cardiac Dysfunction Associated With Dystrophinopathy

Not Applicable

• Conditions: cardiac dysfunction associated with dystrophinopathy

• Registration Number: JPRN-UMIN000007033
• Lead Sponsor: ational Hospital Organization

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-07
• Study Completion: 2014-02-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical composite response

Secondary Outcome Measures

Name	Time	Method
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