cardiac dysfunction associated with dystrophinopathy
Conditions
Interventions
50 patients with dose-escalation based on tolerability
50 patients with dose-escalation based on heart rate reduction
Sponsors
National Hospital Organization
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical composite response | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactHiroshi Okamoto
National Hospital Organization Hokkaido Medical Center Department of Cardiovascular Medicine
Outcome results
None listed