heart failure
Conditions
Interventions
Test group:The starting dose of sacubitril-valsartan is 100 mg twice a day. For patients who have not taken ACE inhibitors or ARBs prior to enrollment, the starting dose is 50 mg bid. As tolerated by
Control group:Peindopril is initially 2 mg once a day in the morning and doubled every 2 to 4 weeks as tolerated until a target maintenance dose of 8 mg once a day is reached.
Sponsors
The Affiliated Hospital of Yunnan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Adult male or female, age > 18 years; 2. Diagnosed chronic heart failure, NYHA cardiac function grade II~IV; 3. Echocardiography showed LVEF = 150 pg/mL (or NT-proBNP >=600 pg/mL), or >= 100 pg/mL (or NT-proBNP >= 400 pg/mL) if hospitalized for heart failure within 12 months prior to the baseline visit; 5. Use of reliable contraception in patients who are not pregnant or fertile patients (male or female); 6. Female patients with potential pregnancy must have a negative pregnancy test at screening; 7. Subjects voluntarily and strictly abide by the requirements of the study protocol and sign a written informed consent form; 8. Able to read, understand, and complete patient questionnaires independently.
Exclusion criteria
Exclusion criteria: 1. History of angioedema (drug-related or other reasons) within 12 months prior to screening; 2. Received acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid artery or other major cardiovascular surgery, PCI or carotid angioplasty within 3 months prior to screening; 3. Acute decompensated heart failure (manifested by signs and symptoms of worsening chronic heart failure, which may require intravenous therapy); 4. Implantation of CRT device or planned implantation of CRT within 3 months prior to screening; 5. Have a history of heart transplantation or be on the transplant list or use a left ventricular assist device; 6. Presence of severe heart valve disease; 7. History of arrhythmia: second- or third-degree atrioventricular block without pacemaker; poorly controlled atrial fibrillation (ventricular rate >= 120 bpm); Family history of long QT syndrome or torsade de pointes, etc.; 8. Symptoms of hypotension and/or systolic blood pressure 5.2 mmol/L; 11. Have a history of severe lung disease; 12. History of malignancy in any organ system (treated or untreated, regardless of whether there is evidence of local recurrence or metastasis, except for local basal cell carcinoma of the skin); 13. Patients who are intolerant to the study drug, drugs of a similar chemical class, ACE inhibitors, ARBs, or neprilysin inhibitors, and who have known or suspected contraindications to the study drug; 14. Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of the study drug, including but not limited to: history of active inflammatory bowel disease within 12 months prior to screening, active duodenal ulcer or gastric ulcer within 3 months prior to screening, liver function (ALT, AST, TBL) results = 3 times the upper limit of normal, history of hepatic encephalopathy, history of esophageal varices or history of portal cava shunt; 15. Pregnant or lactating women, patients of childbearing potential who are unwilling or unable to take effective contraceptive measures; 16. Participant in another clinical study, use of any exploratory medication or participation in an observational study within 30 days prior to the subject's baseline visit; 17. Other circumstances that may affect the conduct of clinical research and the judgment of research results as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in N-terminal forebrain natriuretic peptide (NT-proBNP) levels after 12 weeks of treatment;; | — |
Secondary
| Measure | Time frame |
|---|---|
| After 12 weeks of treatment, cardiac function measures improved (left ventricular ejection fraction (LVEF), left ventricular diastole/end-systolic diameter;After 12 weeks of treatment, MLHFQ Heart Failure Quality of Life Questionnaire score (assessing heart failure symptoms and physical limitations);After 12 weeks of treatment, mortality from cardiovascular causes;Hospitalization rate for heart failure after 12 weeks of treatment; | — |
Countries
China
Contacts
Public ContactZhang Xinjin
The Affiliated Hospital of Yunnan University
Outcome results
None listed