HFrE
Conditions
Interventions
S086 tablets group:1.Initiation period: Sacubitril Valsartan Sodium Tablets 100mg bid+S086 tablets placebo for 2 weeks, then S086 tablets 120mg bid+ Sacubitril Valsartan Sodium Tablets placebo for 2 w
Sacubitril Valsartan Sodium Tablets group:1.Initiation period: Sacubitril Valsartan Sodium Tablets 100mg bid+S086 tablets placebo for 2 weeks, then S086 tablets 120mg bid+ Sacubitril Valsartan Sodium
Sponsors
Peking Union Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-75 years old, male or female; 2. Patients with chronic heart failure (NYHA grade II-IV) with reduced ejection fraction (LVEF=150 pg/mL or NT-probNP >=600 pg/mL at visit 1(patients who are receiving Sacubitril Valsartan Sodium Tablets treatment must use NT-probNP to confirm eligibility); If hospitalization for heart failure within 12 months before visit 1, BNP>=100 pg/mL or NT-probNP >= 400 pg/mL can be accepted (patients who are receiving Sacubitril Valsartan Sodium Tablets treatment must use NT-probNP to confirm eligibility); 3. Patients received a steady dose of basic heart failure medications (including angiotensin-converting enzyme inhibitors, angiotensin receptor antagonists, beta-blockers, oral diuretics, aldosterone receptor antagonists, and sakobactrol valsartan) that had not changed for at least 4 weeks prior to screening; 4. Voluntarily participate in the experiment and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Novel coronavirus nucleic acid test positive at visit 1 or within 30 days prior to visit 1, or close contact with a confirmed or suspected COVID-19 patient, or a confirmed or suspected COVID-19 patient himself; 2. Continuous administration of Sacubitril Valsartan Sodium Tablets 150mg bid or above for more than 3 months; 3. Use other study drugs at visit 1 or within 30 days prior to visit 1 or during 5 drug half-lives, whichever is longer. Any study medical devices are being used; 4. Known or suspected allergy to S086, Sacubitril Valsartan Sodium, ARB, ACEI or NEPI, or known or suspected contraindication to Sacubitril Valsartan Sodium; 5. Past medical history of intolerance to the recommended target dose of ACEI or ARB; 6. Simultaneous treatment with ACEIs and ARBs is required; 7. Current acute decompensated heart failure (symptoms and signs indicating increased chronic heart failure that may require intravenous medication); 8. History of angioedema; 9. Serum potassium > 5.0mmol/L at visit 1(screening), or serum potassium >= 5.5mmol/L at visit 3(random); 10. Symptomatic hypotension and/or SBP 2.5 times ULN or eGFR(estimated by MDRD formula) 2 times ULN at visit 1; 13. HIV or HCV or TP antibody positive, or HBsAg positive with HBV DNA >=1000U/mL; 14. Hemoglobin < 60g/L at visit 1; 15. Acute coronary syndrome occurred within 6 weeks prior to visit 1; 16. Stroke, transient ischemic attack, major cardiac or carotid surgery(such as coronary artery bypass grafting, percutaneous coronary intervention, or carotid angioplasty) occurred within 3 months prior to visit 1; 17. Coronary or carotid artery disease that is expected to require surgery or percutaneous intervention within 6 months after visit 1; 18. Implantation of a CRT-P or a CRT-D or upgrading of an existing conventional pacemaker or ICD to a CRT device within 3 months prior to or expected 3 months after visit 1, or implantation of traditional pacemaker or ICD within 1 month prior to visit 1; 19. Prior or expected heart transplantation or left ventricular assist device (LVAD) implantation within 3 months; 20. Diagnosed with perinatal or chemotherapy-induced cardiomyopathy within 12 months prior to visit 1; 21. Evidence of untreated ventricular arrhythmias with syncope episodes occurring within 3 months prior to visit 1; 22. Symptomatic bradycardia or degree II type II or degree III heart block without pacemaker; 23. Patients with valvular heart disease requiring surgery or intervention, or within 3 months after valve surgery or intervention; 24. Obstructive hypertrophic cardiomyopathy or constrictive pericarditis; 25. Atrial fibrillation or atrial flutter with resting heart rate greater than 100 BPM was recorded by electrocardiogram at visit 3(random); 26. Bilateral renal artery stenosis; 27. Chronic lung disease requiring at-home oxygen, oral hormone or bronchodilators, or hospitalization for an episode within the previous 12 months, or chronic lung disease considered significant by the investigator, or primary pulmonary hypertension. 28. History of malignant tumor within 5 years prior to visit 1; 29. Any surgical or medical condition that may significantly alter the study of drug absorption, distribution, metabolism or excretion, in
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| NT-proBNP;New York Heart Association (NYHA) Classification;Kansas City Cardiomyopathy Questionnaire (KCCQ);Left Ventricular End-Diastolic Volume Index, LVEDVI;Left Ventricular End-systolic Volume Index, LVESVI;Left Atrial Volume Index, LAVI;E/e'; | — |
Countries
China
Contacts
Public ContactShuyang Zhang
Peking Union Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed