ITMCTR2000003440
Recruiting
Phase 1
Efficacy and Safety Evaluation of Lingguizhugan Decoction in Treating Heart Failure With Mid Range Ejection Fraction
Hospital of Chengdu University of Traditional Chinese Medicine0 sitesTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients aged 18\-75 years;
- •2\. Newly discovered patients with chronic heart failure are treated with stable and standardized guidelines for more than 3 months;
- •3\. Meet the diagnostic conditions of HFmrEF:
- •(1\) Have symptoms and/or signs of heart failure;
- •(2\) LVEF40%49%;
- •(3\) Increased natriuretic peptide levels (B\-type brain natriuretic peptide, BNP \>\= 35 pg/ml or N\-terminal BNP precursor, NT\-proBNP \>\=125 pg/ml)
- •(4\) Related structural heart diseases: left ventricular hypertrophy (male left ventricular mass index \>\= 115g/m2, female \>\= 95g/m2\) or left atrial enlargement (left atrial volume index \> 34ml/m2\) or diastolic dysfunction.
- •4\. After more than two weeks of the washout period of Chinese medicine/Chinese patent medicine;
- •5\. Heart failure caused by hypertension and underlying coronary heart disease;
- •6\. Patients with cardiac function grade NYHA II/III;
Exclusion Criteria
- •1\. Heart failure is accompanied by severe heart valve disease, congenital heart disease, pericardial disease, cardiomyopathy, acute cardiovascular events in the past month, unstable angina, acute myocarditis and infective endocarditis;
- •2\. Cerebrovascular accident and severe pulmonary vascular disease occurred in the last 6 months;
- •3\. Severe liver and kidney dysfunction, in which creatinine \> 265µmol/L
- •4\. Merging serious diseases or malignant tumors of other systems;
- •5\. Women who are pregnant or breastfeeding or have recent birth planning;
- •6\. People with allergies, mental illnesses and infectious diseases;
- •7\. Acute infection, sepsis and sepsis;
- •8\. Known intolerance to long\-term use of Chinese medicine;
- •9\. Patients who are participating or have participated in other clinical trials within the past three months;
- •10\. The investigator believes that it is not appropriate to participate in other conditions of this experiment.
Outcomes
Primary Outcomes
Not specified
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