Premature ventricular complexes
Conditions
Interventions
Test group:Dronedarone 400mg bid (morning and evening with meals), for 3 months
Control group:Metoprolol, 25mg bid, for 3 months
Sponsors
The First Affiliated Hospital with Nanjing Medical University (Jiangsu Province Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18 to 75, regardless of gender; 2. Frequent idiopathic RVOT premature ventricular complexes accompanied by palpitations (Premature beats measured by 24-hour ambulatory electrocardiogram > 5000 times/24h, in recent 1 month), with or without unsustained ventricular tachycardia; 3. Informed consent signed.
Exclusion criteria
Exclusion criteria: 1. Hypersensitivity and intolerance to the active substance of dronedarone or metoprolol; 2. Persistent ventricular tachycardia; 3. Severe organic heart disease; 4. Bradycardia (24-hour average heart rate 240 msec or 2nd degree or 3rd degree atrioventricular block or sick sinus syndrome; 6. Patients with hemodynamic instability, including NYHA class III/IV heart failure or recent cardiac decompensation requiring hospitalization; 7. QTc Bazett interval >=500 ms, or concomitant use of drugs or herbal products that prolong the QT interval and might increase the risk of Torsade de Pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain oral macrolide antibiotics; 8. Concomitant use of strong CYP3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, and ritonavir; 9. Liver function: among which AST or ALT>=2.5 times the upper limit of normal value TBIL>=1.5 times the upper limit of normal value.Hypersensitive pneumonia or interstitial pneumonia related to the previous use of amiodarone; 10. Before enrollment, the discontinuation time of other antiarrhythmic drugs was less than 5 half-lives; 11. Severe electrolyte abnormality (serum potassium <3.5mmol/L or serum magnesium <0.75mmol/L); 12. Systolic blood pressure <100mmHg in patients with suspected acute myocardial infarction; 13. Patients with severe peripheral vascular disease associated with the risk of gangrene; 14. Within 6 months or will undergo major surgery; 15. Complicated with hematopoietic diseases, psychosis, malignant tumors and other major diseases, life expectancy less than 1 year; 16. Pregnancy and Nursing mothers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of ventricular premature beats; | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of ventricular premature beats;The proportion of patients with premature ventricular contractions 1 and 3 months after treatment decreased by > 90% compared with those before enrollment (day 15-0 of screening period);The proportion of patients with premature ventricular contractions reduced by 50%-90% after 1 and 3 months of treatment compared with before enrollment;Assessment of patients' quality of life at 1 and 3 months of treatment (SF-36 Quality of Life Scale); | — |
Countries
China
Contacts
Public ContactZhang Fengxiang
The First Affiliated Hospital of Nanjing Medical University
Outcome results
None listed