Coronary Heart Disease Heart Failure
Conditions
Interventions
Control group:Placebo plus standard treatment for heart failure
Experimental group:QSXZY plus standard treatment for heart failure
Sponsors
Dong Fang Hospital , Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
30 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age 30 to 85 years, no gender restrictions; (2) Meets the aforementioned diagnostic criteria for coronary heart disease with heart failure; (3) Diagnosed with qi deficiency and blood stasis syndrome according to Traditional Chinese Medicine (TCM) pattern differentiation; (4) New York Heart Association (NYHA) functional class II-III (hemodynamically stable); (5) Fully understands the study objectives, voluntarily participates in the trial, and signs an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with chronic heart failure who have undergone implantation of a cardiac resynchronization therapy device or implantation of a cardioverter-defibrillator within the past 12 weeks, or who are scheduled to undergo such device implantation within the next 12 weeks; (2) Patients with concomitant cardiogenic shock, acute myocarditis, uncontrollable malignant arrhythmias, obstructive hypertrophic cardiomyopathy, constrictive pericarditis, cardiac tamponade, severe valvular disease requiring surgical intervention, or pulmonary embolism; (3) Recent onset of non-cardiac conditions affecting exercise capacity, or conditions exacerbated by exercise (e.g., infection, hepatic/renal failure, thyrotoxicosis); (4) Uncontrolled hypertension or hypotension: resting seated systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg; (5) Non-heart failure-related liver transaminase (ALT or AST) levels exceeding 3 times the upper limit of normal, glomerular filtration rate 5.5 mmol/L; (6) Patients with severe primary diseases of the liver, kidneys, hematopoietic system, nervous system, endocrine system, tumors, or psychiatric disorders; (7) Women planning pregnancy, currently pregnant, or breastfeeding; (8) Suspected or confirmed alcohol or substance abuse; (9) Known allergy to any investigational drug; (10) Participation in another drug clinical trial within the past month; (11) Patients currently taking traditional Chinese medicine or proprietary Chinese medicines with ingredients similar to QSXZY; (12) Other reasons deemed by the investigator as unsuitable for participation in this clinical trial, including the investigator's judgment that the patient cannot complete the study or comply with its requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-Minute Walk Test;NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fatigue, Resistance, Ambulation, Illness, Loss of Weight Scale Frailty Scale;IL-6;hs-CRP;D-dimer;Fibrinogen;Glucose and Lipid Metabolism Indicators;TCM-SS;Echocardiogram;MLHFQ;New York Heart Association Functional Classification;Composite endpoint event;All-cause mortality; | — |
Countries
China
Contacts
Public ContactDong Li
Dong Fang Hospital , Beijing University of Chinese Medicine
Outcome results
None listed