sinus node dysfunction
Conditions
Interventions
Intervention group:Shenxian Shengmai Koufuye
Sponsors
Second Hospital of Tianjin Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1) Age = 18 years; 2) After discontinuation of heart rate-affecting medications for at least 5 half-lives, dynamic electrocardiography and/or multiple 12-lead ECG during diurnal hours on different days show any of the following: sinus bradycardia with heart rate 2 seconds; 3) Presence of symptoms related to bradycardia, such as dizziness, fatigue, palpitations, or decreased exercise tolerance; 4) Patients and their families have full knowledge of this study, voluntarily participate, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who underwent or planned to undergo permanent pacemaker implantation, cardiac resynchronization therapy, implantable cardioverter-defibrillator placement or artificial heart valve replacement; 2. Any severe condition such as but not limited to acute myocardial infarction, fulminant myocarditis, aortic dissection, percutaneous coronary intervention, cardiac and major vascular surgery, or poorly controlled diabetes within the past 3 months; 3. Sinus bradycardia caused by reversible factors, such as after coronary artery bypass graft surgery, after valve surgery, hyperkalemia, hypokalemia, hypoglycemia, hypothyroidism, etc. 4. Sinus node dysfunction manifested with any of the following criteria:daytime mean heart rate 5.0s, sinus arrest; 5. Severe symptoms definitively attributable to bradycardia:Adams-Stokes syndrome, sschemic stroke, transient ischemic attack,recurrent syncope or presyncope etc; 6. Heart function(New York Heart Association Function Classification,NYHA) Class III or above,or left ventricular ejection fraction(LVEF) shown by color Doppler echocardiography=35%; 7. Combination of other arrhythmias:second-degree atrioventricular block, high-degree atrioventricular block, third-degree atrioventricular block,bundle branch block,persistent AF,permanent AF, malignant ventricular arrhythmia,ventricular premature contractions (VPCs) burden>10% or >10000beats per 24h on 24-hour Holter monitoring; 8.Uncontrolled hypertension systolic blood pressure (SBP) = 160mmHg and/or diastolic blood pressure (DBP) = 100mmHg; or SBP < 90mmHg and/or DBP <60mmHg; 9. Serious hepatic dysfunction(liver transaminase and alkaline phosphatase=2×upper limit of normal) or Serious renal dysfunction(GFR<30ml/min×1.73m2) 10. Medical conditions that may affect participation in the study, interfere with assessment or treatment, significantly increase study risks, or confuse data and its interpretation, including but not limited to severe pulmonary diseases, pulmonary hypertension, or any pulmonary disease accompanied by abnormal blood gas or significant dyspnea; active malignancy; moderate to severe valve stenosis; congenital heart disease with residual anatomical or conduction abnormalities; 11.Allergic constitution; known to be allergic to research drug; 12.A life expectancy of less than 1 year; 13.Participation in other clinical studies within 3 months prior to the date of informed consent,or ongoing participation in other clinical studies; 14.Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures or any conditions may render the patient unable to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| average heart rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| total number of heart beats per 24 hours;maximal heart rate;minimum heart rate;bradycardia burden;proportion of patients free from bradycardia recurrence within 6 months of follow-up;Proportion of patients receiving permanent pacemaker implantation within 6 months of follow-up;heart rate variability;cardiac structure and function;Short Form 36 Health Survey;N-Terminal Pro-Brain Natriuretic Peptide; | — |
Countries
China
Contacts
Public ContactLiu Tong
Second Hospital of Tianjin Medical University
Outcome results
None listed