Efficacy and safety evaluation of Lingguizhugan Decoction in treating HFmrEF: a study protocol of a randomized controlled trial
- Conditions
- heart failure with mid range ejection fraction
- Registration Number
- ITMCTR2000003440
- Lead Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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;
7. Agree and sign an informed consent form.
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.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Six-minute walk test;NYHA functional class;adverse cardiovascular events;Left ventricular ejection fraction;N-Terminal pro-brain natriuretic peptide (NT-proBNP);
- Secondary Outcome Measures
Name Time Method blood pressure;blood routine examination;liver faction examination;Electrocardiogram;routine urine examination;SF-36 Quality of Life Questionnaire;