Heart Failure
Conditions
Interventions
Treatment group:Standard treatment for heart failure + Qishen Yiqi Dropping Pills (orally, 1 sachet each time, 3 times a day)
control group:Standard treatment for heart failure + placebo (oral administration, 1 sachet each time, 3 times a day)
Sponsors
Fuwai Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Aged = 18 years and = 75 years, regardless of gender; 2) Meeting the diagnosis of HFmrEF and satisfying the following conditions: 1) LVEF between 40% and 50% within 2 weeks before randomization; 2) NT-proBNP > 300 pg/ml (without atrial fibrillation); NT-proBNP > 450 pg/ml (with atrial fibrillation); 3) NYHA cardiac function class II-IV; 4) Having previously received guideline-recommended medications, including SGLT-2 inhibitors and diuretics, with stable doses for more than 4 weeks.
Exclusion criteria
Exclusion criteria: 1) Acute decompensated heart failure with hemodynamic instability, and mechanical hemodynamic support or invasive mechanical ventilation within 14 days before randomization; receiving intravenous inotropic agents, vasoactive agents, or intravenous diuretics within 7 days before randomization; 2) Poorly controlled hypertension, defined as resting systolic blood pressure = 180 mmHg and/or diastolic blood pressure = 110 mmHg in two independent measurements before randomization; 3) Liver transaminases (ALT or AST) or bilirubin exceeding 3 times the upper limit of normal due to non-heart failure causes, and glomerular filtration rate less than 15 ml/min/1.73m²; 4) Patients with hemoglobin concentration = 9 g/dL and/or hematological diseases; 5) Valvular heart disease or congenital heart disease without surgical treatment; 6) Cardiogenic shock; 7) Hypertrophic obstructive cardiomyopathy, restrictive cardiomyopathy, other secondary and infiltrative cardiomyopathies; 8) Active myocarditis; 9) Constrictive pericarditis and other pericardial diseases; 10) A history of syncope within 3 months; 11) Symptomatic bradycardia or second-degree or third-degree heart block without a pacemaker implanted; 12) Malignant ventricular arrhythmias affecting hemodynamics; 13) Implantation of a cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) within 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; 14) Occurrence within 3 months of: acute coronary syndrome, stroke, transient ischemic attack; cardiac, carotid, or other major vascular surgery; percutaneous coronary intervention (PCI) or carotid angioplasty, coronary artery bypass grafting, or other cardiac surgeries; 15) Having undergone major surgery within 6 months before randomization; 16) A history of heart transplantation, being on the waiting list for transplantation, or intention to use a left ventricular assist device (LVAD); 17) Severe chronic obstructive pulmonary disease, cor pulmonale, severe pulmonary vascular disease, pulmonary hypertension caused by autoimmune diseases, and any type of severe pulmonary hypertension; 18) A history of major organ transplantation (such as lung, liver, heart, bone marrow, kidney); 19) Patients with severe primary diseases of the liver, kidney, hematopoietic system, nervous system, endocrine system, etc., tumor patients, and psychiatric patients; 20) Life expectancy of less than 1 year; 21) Known allergy to any trial drug; 22) Participation in other clinical trials of drugs within 1 month; 23) TCM syndrome differentiation of dampness-turbidity internal accumulation syndrome; 24) Inability to discontinue the use of the following Chinese herbal preparations or Chinese herbal preparations with similar ingredients, such as Danshen Injection, Guanxinning Injection, Shuxuening Injection, Ligustrazine Powder Injection, Ginkgo Biloba Extract Preparation, Shexiang Baoxin Pill, Suxiao Jiuxin Pill, Ligustrazine Hydrochloride for Injection, Danshen Ligustrazine Injection, Compound Xueshuantong Capsule, Xueshuantong Injection, Qili Qiangxin Capsule, Shenmai Decoction, Shenmai Injection, Gualou Tablet, etc., as well as Chinese herbal decoctions and in-hospital Chinese herbal preparations containing ingredients such as ginseng, American ginseng, notoginseng, and panax japonicus; 25) Pregnancy (pos
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| death;Number of heart failure readmissions;first-time readmission for heart failure;Worsening Heart Failure;Minnesota Living with Heart Failure Questionnaire Score;Left Ventricular Ejection Fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| New York Heart Association Heart Function Classification;European Quality of Life 5-Dimension 5-Level Score;NT-proBNP;6 minute walking test;TCM syndrome score; | — |
Countries
China
Contacts
Public ContactYuanlin Guo
Fuwai Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed