Heart failure
Conditions
Interventions
Trial group:Take Fuyang Qiangxin Tang Granules, 1 sachet each time, twice a day for 4 weeks.
Control group:Take Placebo, 1 sachet each time, twice daily for 4 weeks.
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Any gender and age 18-85 years; (2) Patients must be randomised at least 24 hours and no later than 5 days after admission to hospital in stable condition; (3) Patients should meet the following prior to enrolment during hospitalisation: no intravenous vasodilators, including nitrates, during the last 6 hours prior to randomisation; and no intravenous positive inotropic drugs 24 hours prior to randomisation to group; (4) Measurement of NT-proBNP =1600 pg/mL or BNP =400 pg/mL during hospitalisation or within 72 hours prior to admission. for patients with atrial fibrillation: NT-proBNP =2400 pg/mL or BNP =600 pg/mL; for patients older than 75 years of age NT-proBNP =2000 pg/mL needs to be met; (5) Treatment with a minimum dose of 40 mg intravenous furosemide or equivalent; (6) Chinese medicine diagnosis of Yang deficiency and water flooding evidence. The diagnostic criteria for TCM evidence were: main symptom + at least two concurrent symptoms; main symptom: chest tightness, wheezing and inability to lie down, dysuria, cough/phlegm, shortness of breath/wheezing, and fatigue. Symptoms: 1) fear of cold and/or warmth; 2) cold feeling in the stomach and epigastrium/abdomen/lumbar/limb; 3) cold sweat; 4) dark colour of the face/mouth and lips; 5) palpitation; 6) fullness in the chest/abdominal distension; 7) puffiness in the face/swelling of the limbs. (7) Subjects voluntarily enrolled in this study, signed the informed consent, good compliance, and can cooperate with the follow-up.
Exclusion criteria
Exclusion criteria: 1) Current hospitalisation for acute heart failure primarily due to pulmonary embolism, cerebrovascular accident or acute myocardial infarction; 2) Planned interventions within 30 days prior to enrolment or during the study period: major cardiac surgery, or TAVI, or PCI, or MitraClip; implantation of a cardiac resynchronisation therapy device; implantation of cardiac mechanical support; and carotid artery disease revascularisation; 3) Patients with current or anticipated heart transplantation, left ventricular assist device, intra-aortic balloon pump, or planned positive inotropic support in the outpatient setting; 4) Patients who have been taking traditional Chinese medicine such as Yiqi and blood activation or Qi and blood activation in the last 1 month or who have been participating in other clinical trials in the last 1 month; 5) Primary heart valve disease with severe uncorrected haemodynamics for which surgery or intervention is planned during the course of the study; 6) Patients with eGFR <20mL/min/1.73m2 or requiring dialysis during hospitalisation; 7) Patients with significant hepatic disorders or ALT and AST both higher than 3 times the upper limit of normal; 8) New York Heart Function (NYHA) class IV, or combined with recurrent malignant arrhythmias; (9) Combined chronic obstructive pulmonary disease or even respiratory failure, or combined lung infection; 10) Diabetic patients with random blood glucose =13.7mmol/L or glycated haemoglobin =9.5%; (patients with poor blood glucose control) (11) Pregnant or preparing for pregnancy women, lactating women; 12) Patients with combined acute cerebrovascular disease; malignant tumours or patients with a life expectancy of less than 1 year; patients with severe haematopoietic disorders; 13) Patients with severe psychiatric disorders; 14) Patients who are allergic to known components of the study drug. 15) Patients with ejection fraction = 30%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| NT-proBNP; | — |
Secondary
| Measure | Time frame |
|---|---|
| New York Heart Association (NYHA) Classification ;Chinese Medicine Score;Echocardiographic values;Distance of the six-minute walk test;Kansas City Cardiomyopathy Questionnaire-Total Symptom Score (KCCQ-TSS) score;PHQ-9 Depression Screening Scale; GAD-7 Anxiety Screening Scale;total cholesterol;low density lipoprotein (LDL);high density lipoprotein (HDL); | — |
Countries
China
Contacts
Public ContactLI HAIXIA
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed