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This study aims to investigate the efficacy and safety of oral sotalol alone or combination with other anti-arrhythmic medicines in the treatment of arrhythmias in children. The study will regularly monitor the Holter, electrocardiogram (ECG), Echocardiography (Echo), blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, N-terminal pro-brain natriuretic peptide (NT pro-BNP), etc, before and after receive sotalol therapy. Compare the degree of arrhythmia improvement in patients and the side effects after oral sotalol.
Monitoring the Holter, ECG, Echocardiography , blood routine, urine routine, serum ion, liver and kidney function, troponin I, hypersensitive troponin T, NT pro-BNP beforehand. Eligible patients should stop all anti-arrhythmia drugs and digitalis, tricyclic antidepressants, beta blockers or calcium antagonists for at least 5 half-lives, and then do Holter. Randomly grouped. Judging the results according to the situation before and after oral sotalol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sotalol | Experimental | Oral sotalol 2.5mg/kg/time, per 12h. Combination therapy: betaloc |
|
| Propafenone | Active Comparator | Oral Propafenone 5mg/kg/time, pre 8h Combination therapy: betaloc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sotalol | Drug | Oral sotalol 2.5mg/kg/time, per 12h |
| |
| Propafenone |
| Measure | Description | Time Frame |
|---|---|---|
| QT interval of ECG | 1 week | |
| QT interval of ECG | 3 month |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | 1 week, 3 month | |
| Red Blood Cell (RBC) | The indicator is obtained through blood routine. | 1 week, 3 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hong Wang, MD | Contact | 86-18940251677 | wanghong_64@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenjing Hospital | Shenyang | Liaoning | 110004 | China |
Dear Sir/Madam Our study receives a grant from China Ministry of Science and Technology. We cannot decide whether the data could be shared. Hope you can understand.
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013015 | Sotalol |
| D011405 | Propafenone |
| D008790 | Metoprolol |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
Oral Propafenone 5mg/kg/time, pre 8h |
|
| betaloc | Drug | Oral betaloc 0.5mg/kg/time ,pre 12h |
|
| Wed Blood Cell (WBC) |
The indicator is obtained through blood routine. |
| 1 week, 3 month |
| Hemoglobin | The indicator is obtained through blood routine. | 1 week, 3 month |
| Platelet | The indicator is obtained through blood routine. | 1 week, 3 month |
| Albumin | The indicator is obtained through liver function test. | 1 week, 3 month |
| Alanine aminotransferase (ALT) | The indicator is obtained through liver function test. | 1 week, 3 month |
| Aspertate aminotransferase (AST) | The indicator is obtained through liver function test. | 1 week, 3 month |
| Creatinine | The indicator is obtained through kidney function test. | 1 week, 3 month |
| D000588 |
| Amines |
| D011427 | Propiophenones |
| D007659 | Ketones |
| D050198 | Phenoxypropanolamines |
| D011412 | Propanolamines |
| D020005 | Propanols |