Heart failure
Conditions
Interventions
Experimental group:Receive guideline-guided drug treatment combined with TCM comprehensive intervention
Control group:Receive guideline-guided medication + routine education
Sponsors
Shanxi Provincial Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Voluntary participation with understanding; patients must sign the informed consent form before the evaluation project. 2.Age = 18 years and = 80 years, regardless of gender. 3.Patients with chronic heart failure (syndromes of Qi deficiency and blood stasis, Qi and Yin deficiency, or Yang deficiency and water overflow), NYHA class II–III, with Simpson's echocardiography performed within one week prior to enrollment showing: LVEF = 40% (HFrEF) or LVEF = 50% (HFpEF). 4.NT-proBNP levels measured within one week prior to enrollment: a. HFrEF (LVEF = 40%): NT-proBNP = 400 pg/mL; in cases of atrial fibrillation, = 800 pg/mL. b. HFpEF (LVEF = 50%): NT-proBNP = 300 pg/mL; in cases of atrial fibrillation, = 600 pg/mL. 5.Screening period: Patients diagnosed with heart failure (based on previous medical records, echocardiography, or cardiac MRI) and who have received treatment for acute exacerbation of chronic heart failure, are in stable condition, have discontinued intravenous preparations, and have completed standardized drug therapy, with no changes in the types, dosages, or administration methods of standardized treatment drugs. Standardized drug therapy includes: angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), sacubitril/valsartan (ARNI), beta-blockers, mineralocorticoid receptor antagonists (MRA), SGLT2 inhibitors, and diuretics. 6.During the screening period, the types, dosages, and administration methods of the standardized treatment drugs for chronic heart failure must remain relatively unchanged prior to enrollment; and intravenous cardiac glycosides must not be used within five days (including the fifth day) prior to enrollment. 7.Patients must meet the criteria for one of the TCM syndromes: Qi deficiency and blood stasis, Qi and Yin deficiency, or Yang deficiency and water overflow.
Exclusion criteria
Exclusion criteria: (1) Hemodynamically unstable acute decompensated heart failure, and those who received mechanical hemodynamic support or invasive mechanical ventilation within 14 days prior to enrollment; those who used oral cardiac glycosides, received intravenous cardiac glycosides, vasoactive drugs, or intravenous diuretics within 5 days (including the 5th day) prior to enrollment; (2) Poorly controlled hypertension, defined as resting systolic blood pressure =160 mmHg and/or diastolic blood pressure =110 mmHg on two separate checks prior to enrollment; (3) Symptomatic hypotension and/or systolic blood pressure 150 beats/min); (7) History of syncope within the past 3 months; (8) Known cardiomyopathy based on infiltrative diseases (e.g., amyloidosis), storage diseases (e.g., hemochromatosis, Fabry disease), muscular dystrophy, hypertrophic obstructive cardiomyopathy, or cardiomyopathy diagnosed prior to Visit 1 with a potentially reversible cause, such as stress-induced or peripartum cardiomyopathy, or chemotherapy-induced cardiomyopathy; (9) Active myocarditis; (10) Uncorrected congenital heart disease, severe valvular stenosis or regurgitation; (11) Constrictive pericarditis and other pericardial diseases including moderate to large pericardial effusion; (12) Liver transaminases (ALT or AST) or total bilirubin >3 times the upper limit of normal (ULN) due to heart failure; liver transaminases (ALT or AST) or total bilirubin >2 times ULN due to non-heart failure causes; severe infectious diseases such as AIDS, hepatitis C virus infection with hepatic insufficiency (ALT or AST = 2 times ULN); active hepatitis B with hepatic insufficiency (ALT or AST = 2 times ULN); (13) Renal impairment, defined as eGFR <20 mL/min/1.73m² (CKD-EPI) at Visit 1, or requiring dialysis; (14) Hemoglobin concentration =9 g/dL and/or patients with severe hematological diseases; (15) Occurrence within the past 3 months of: acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid, or other major vascular surgery; percutaneous coronary intervention (PCI) or carotid angioplasty or coronary artery bypass grafting and other cardiac surgeries; (16) Major surgery within 6 months prior to enrollment; (17) Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) within the past 6 months, or upgrade of an existing conventional pacemaker or implantable cardioverter-defibrillator (ICD) to a CRT device, or intention to implant a similar device within 6 months; (18) History of heart transplantation within the past 6 months, or currently awaiting transplantation, or intention to use a left ventricular assist device (LVAD); (19) Severe chronic obstructive pulmonary disease, severe cor pulmonale, severe pulmonary vascular disease, severe asthma, and any type of severe pulmonary hypertension; (20) Patients with active tuberculosis, etc.; (21) Severe autoimmune diseases, such as systemic lupus erythematosus; (22) Patients with concurrent severe primary diseases of the liver, hematopoietic system, nervous system, endocrine system, etc., or patients with uncured malignant tumors; (23) Pa
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-minute walk test,6MWT;Minnesota Heart Failure Quality of Life Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiac function grading New York grading;N-terminal pro-B-type Natriuretic Peptide;Cardiac color Doppler ultrasonography;Traditional Chinese medicine syndrome (qi deficiency and blood stasis syndrome, qi and yin deficiency syndrome, yang deficiency and water pan syndrome) points;Anxiety and Depression Scale score;All-cause mortality and readmission rate; | — |
Countries
China
Contacts
Public ContactQu Qiaofang
Shanxi Provincial Cardiovascular Hospital
Outcome results
None listed