sinus bradycardia
Conditions
Interventions
control group:placebo
intervention group:Xinfu Mai No. 1 Formula
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Age =18 years old =80 years old; (2) According to the diagnostic criteria of "Chinese Expert Consensus on the Evaluation and Management of Patients with Bradycardia and conduction Abnormalities 2020" and "Practical Internal Medicine ·14 Edition" patients with sinus rhythm rate =55 beats/min and =35 beats/min were determined to be included in this study. (3) According to the syndrome differentiation criteria of heart-kidney Yang deficiency and blood stasis syndrome: main symptoms: chest tightness dizziness amaurosis shortness of breath and fatigue; Secondary symptoms: soreness and weakness of waist and knees fear of cold and cold limbs dark complexion dark purple or light fat tongue heavy and thin astringent or slow pulse can be diagnosed when meeting two main symptoms one secondary symptom and tongue and pulse. (4) not taking any drugs affecting heart rate in the past week; (5) All subjects voluntarily participated in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: (1) patients undergoing elective cardiac pacemaker implantation; (2) sinus arrest =5s; (3) complicated with conduction block such as atrioventricular block sinoatrial block etc. (4) bradycardia caused by drug endocrine metabolic electrolyte disorders and sleep apnea; (5) structural heart disease requiring surgical or interventional therapy; (6) hypertrophic obstructive cardiomyopathy restrictive cardiomyopathy dilated cardiomyopathy active myocarditis infective endocarditis constrictive pericarditis or other pericardial diseases; (7) complicated with tachyarrhythmia such as atrial fibrillation atrial flutter frequent premature ventricular contractions frequent premature atrial contractions ventricular tachycardia supraventricular tachycardia etc. (8) poorly controlled hypertension; (9) pregnant or lactating women or those who plan to become pregnant; (10) patients with severe primary diseases or dysfunction of lung liver kidney hematopoietic system immune system etc. (11) participants who participated in other drug clinical trials or intervention studies within 4 weeks before the study; (12) patients with allergic constitution or allergy to known components of study drugs; (13) those who were deemed unsuitable for clinical trial participation by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average heart rate of 24-hour ambulatory electrocardiogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour total heartbeat;SF-36 Quality of Life Scale;12-lead electrocardiogram;Heart rate variability index;Score of the TCM Syndrome Scale;The fastest heart rate on 24-hour ambulatory electrocardiogram;The slowest heart rate on a 24-hour ambulatory electrocardiogram;Number of long RR intervals;The implantation status of pacemakers;Long RR interval time; | — |
Countries
China
Contacts
Public ContactMa Lihong
Fuwai Hospital Chinese Academy of Medical Sciences
Outcome results
None listed