heart failure
Conditions
Interventions
control group:Base Western medicine therapy combined with placebo
Experimental group:Base Western medicine therapy combined with xinyang tablet
Sponsors
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1.Diagnosed with chronic congestive heart failure with NYHA functional classification II-IV left ventricular ejection fraction =40% or BNP =200 pg/ml 2.Meets the TCM differentiation criteria for Qi-Yin deficiency with blood stasis and fluid retention syndrome** 3.Age between 18 and 90 years 4.Has received at least 2 weeks of fixed-dose optimal pharmacological treatment according to the 2018 version of the Chinese Guidelines for the Diagnosis and Treatment of Chronic Heart Failure 5.Has discontinued the use of traditional Chinese medicine for heart failure for more than 2 weeks
Exclusion criteria
Exclusion criteria: 1.Acute heart failure 2.Patients with cardiogenic shock life-threatening arrhythmias second-degree type II or higher atrioventricular conduction block obstructive cardiomyopathy severe valvular disease constrictive pericarditis cardiac tamponade pulmonary embolism acute myocardial infarction and those with conditions that affect the efficacy and safety assessment of heart failure medications. 3. Patients with severe pulmonary liver and renal dysfunction as well as serious primary diseases of the endocrine and hematopoietic systems. 4.Patients with exacerbated heart failure symptoms due to digitalis toxicity. 5.Pregnant or breastfeeding women 6.Patients who are unable to complete the 6-minute walk test. 7.Patients with comorbid psychiatric disorders or those unwilling to cooperate. 8.Participants who have participated in other investigational drugs within the past four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Brain Natriuretic Peptide (BNP);Heart function efficacy evaluation criteria (according to NYHA classification method) ;6-minute walk test;Traditional Chinese medicine syndrome efficacy evaluation criteria ;Quality of life; | — |
Secondary
| Measure | Time frame |
|---|---|
| composite endpoint incidence of major adverse cardiovascular events;Rate of readmission;blood count;electrolyte tests;liver function tests;renal function tests;electrocardiogram (ECG); Echocardiogram data;Urinalysis; | — |
Countries
China
Contacts
Public ContactLi Zhifang
Shenzhen Hospital of Integrated Traditional Chinese and Western Medicine
Outcome results
None listed