permanent atrial fibrillation
Conditions
Interventions
methyldigoxin, 12 months
bisoprolol fumarate, 12 months
Sponsors
Department of Cardiology, Nagoya University Graduate School of Medicine
KARIYA TOYOTA General Hospital Konan Kosei Hospital Tsushima City Hospital TOYOTA Memorial Hospital Nagoya Central Hospital Meijo Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have permanent atrial fibrillation 2) Patients who have chronic heart failure 3) Patients who are aged 20 years or older and less than 90 years at the time of obtaining informed consent 4) Patients who have personally and voluntarily provided written informed consent, after having received and thoroughly understood an adequate explanation about participation in the study. 5) Ambulatory patients 6) Patients without rate control against permanent atrial fibrillation , in principle
Exclusion criteria
Exclusion criteria: 1) Patients receiving digitalis preparations or beta blockers 2) Patients with organic heart diseases, such as valvular diseases. 3) Patients with obstructive cardiomyopathy, such as idiopathic hypertrophic subaortic stenosis 4) Patients with severe bradycardia (marked sinus bradycardia), 2nd or 3rd degree atrioventricular block, sinoatrial block, or sick sinus syndrome 5) Patients with bradycardia less than 50 beats/min 6) Patients with digitalis intoxication 7) Patients with diabetic ketoacidosis or metabolic acidosis 8) Patients with cardiogenic shock 9) Patients with right heart failure secondary to pulmonary hypertension 10) Patients with heart failure necessary to administer cardiac stimulants or vasodilators intravenously 11) Patients with decompensated heart failure 12) Patients with severe peripheral artery disease 13) Patients with untreated pheochromocytoma 14) Patients with a history of hypersensitivity to any of the ingredients of the experimental drugs 15) Patients with severe hepatic disease (e.g. AST(GOT) levels or ALT(GPT) levels > 100U IU/L) 16) Patients with severe renal disease (e.g. BUN levels > 25 mg/dL or serum creatinine levels > 2.0mg/dL) 17) Women of confirmed or potential pregnancy 18) Nursing patients 19) Patients who participated in other clinical trials within 3 months of administrating the experimental drugs 20) Patients who are judged unsuitable for this study by the doctor in charge of the patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| left atrial dimension and BNP at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. left atrial dimension and BNP at 6 months 2. LVEF and left ventricular mass index at 6 and 12 months | — |
Countries
Japan
Contacts
Public ContactYasuya Inden
Nagoya University Graduate School of Medicine Department of Cardiology
Outcome results
None listed