Bradycardia
Conditions
Interventions
Test group:Xinbao Pill Dosage and Administration: Oral administration Patients without current indication for permanent cardiac pacemaker implantation: 1.1 Low-dose group: 24-hour Holter monitoring s
1.2 Medium-dose group: 24-hour Holter monitoring shows mean heart rate 50 = HR 3 and =3.5 seconds: 4 pills, three times daily
High-dose group: Patients in the post-implantation programmed follow-up period: 5–10 pills, three times daily
The investigator may adjust the above recommended doses individually based on the patient's actual condition.
Sponsors
Guangdong Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Aged =18 years, regardless of gender; 2.Meet the diagnostic criteria for bradycardia: 2.1 Diagnosed with sinus bradycardia or sinus node dysfunction, but without current indication for permanent cardiac pacemaker implantation (e.g., 24-hour Holter monitoring shows mean heart rate 50 = HR 2 and =3.5 seconds); 2.2 Patients who have received a permanent cardiac pacemaker due to significant sinus bradycardia and are in the post-implantation programmed follow-up period. 3.Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.History of glaucoma; 2.Bradycardia secondary to other diseases or other causes (e.g., acute myocardial infarction, electrolyte disturbance, hypoglycemia, hypothyroidism, acute severe infection with organ dysfunction, etc.); 3.Patients with severe cardiovascular diseases [poorly controlled hypertension >150/90 mmHg, New York Heart Association (NYHA) Class IV heart failure, World Health Organization Functional Classification (WHO-FC) Class II or above pulmonary hypertension], severe hepatic or renal dysfunction (e.g., ALT, AST >2 times the upper limit of normal; estimated glomerular filtration rate <30 mL/min/1.73 m²), rheumatic diseases, malignant tumors, or life expectancy <1 year; 4.Participation in other drug studies within 1 month prior to screening; 5.Pregnant or lactating women, and patients with psychiatric disorders; 6.Known allergy to any ingredient of the study drug, or allergic constitution; 7.Patients deemed unsuitable for participation by the investigators (e.g., athletes with long-term resting heart rate <60 bpm).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate after 8 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes from baseline in the number of long R-R intervals and the longest R-R interval (seconds) on 24-hour ambulatory electrocardiography after 8 weeks of treatment.;Changes from baseline in total heart beats, minimum heart rate, and maximum heart rate on 24-hour ambulatory electrocardiography after 8 weeks of treatment.;Changes from baseline in heart rate variability (HRV) time-domain analysis parameters after 8 weeks of treatment.;Changes from baseline in mean heart rate on 24-hour ambulatory electrocardiography after 8 weeks of treatment.;Incidence of cardiovascular events at 4 and 8 weeks of treatment.;Changes from baseline in symptom scale assessment at 4 and 8 weeks of treatment.;Changes from baseline in SF-12 Health Survey assessment at 4 and 8 weeks of treatment.; | — |
Countries
China
Contacts
Public ContactDeng Hai
Guangdong Provincial People's Hospital
Outcome results
None listed