coronary heart disease with chronic heart failure
Conditions
Interventions
Low-dose group:Western medicine routine treatment + Jiashen tablet 2 tablets/time+Jiashen tablet placebo 2 tablets/time
High-dose group:Western medicine routine treatment + Jiashen tablet 4 tablets/time
placebo group :Western medicine routine treatment + Jiashen tablet placebo 4 tablets/time
Sponsors
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
40 Years to 79 Years
Inclusion criteria
Inclusion criteria: (1) Age 40-79 years (including boundary) gender is not limited; (2) Conform to the western medicine diagnostic criteria for coronary heart disease and chronic heart failure; (3) Conform to the traditional Chinese medicine syndrome differentiation criteria for yang qi depletion and blood stasis syndrome in chronic heart failure; (4) NYHA heart function grade II-III (including boundaries); (5) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1)Patients with acute exacerbation of chronic heart failure or who still need intravenous drug treatment; (2)Patients who have undergone cardiac resynchronization therapy (CRT) and other heart failure device assisted therapies; (3)Individuals who have experienced acute coronary syndrome stroke transient ischemic attack or cardiac surgery such as revascularization (PCI CABG) within the first 3 months of randomization; (4)Patients planning to undergo cardiac surgery such as revascularization (PCI CABG) or cardiac resynchronization therapy (CRT) during the trial period; (5)Severe arrhythmia [such as persistent atrial fibrillation permanent atrial fibrillation ventricular tachycardia type II or above sinoatrial or atrioventricular block without pacemaker treatment QT interval (QTc) after heart rate correction according to Fridericia's formula exceeding 480 ms or known history or symptoms of long QT syndrome]; (6) Patients with uncontrolled hypertension (systolic blood pressure =180 mmHg and / or diastolic blood pressure =110 mmHg) or hypotension (systolic blood pressure 5.5 mmol/l or hemoglobin (HB) < 90 g / L; Malignant tumor serious neuroendocrine system disease and mental disease; (9) Women who are pregnant or preparing for pregnancy and lactation; (10) Participated in other interventional clinical studies within 1 month before screening; (11) Allergic constitution or those who are known to be allergic to the traditional Chinese medicine of Jiashen tablets (such as Xiangjiapi Danshen etc.); (12) The investigator judged that the patient could not complete the study or comply with the requirements of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6MWD; | — |
Secondary
| Measure | Time frame |
|---|---|
| NT-proBNP;Main symptoms / signs of heart failure;MLHFQ Score;Echocardiographic indexes;Major adverse cardiovascular events (cardiovascular death hospitalization for worsening heart failure non fatal Hospitalization for myocardial infarction hospitalization for nonfatal stroke) incidence;NYHA;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactMao Jingyuan
The First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed