Heart failure
Conditions
Interventions
experimental group:Sacubitril /Valsartan
control group:enalapril
Sponsors
Chongqing Kanghua Zhonglian Cardiovascular Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Hospitalized patients of ADHF; (2) Aged >= 18 years, male or female; (3) Left ventricular ejection fraction = 1600pg/mL or BNP >= 400pg /mL(if the natriuretic peptide did not meet the above criteria, patients who had received a primary diagnosis of ADHF including signs and symptoms of fluid overload. Patients with dyspnea due to non-cardiac causes, such as acute or chronic respiratory disorders were excluded.); (5) NYHA class level II-IV.
Exclusion criteria
Exclusion criteria: 1. Currently taking sacubitril/valsartan or any use within the past 30 days; 2. Enrollment in any other clinical trial involving an investigational agent or device; 3. History of hypersensitivity, known or suspected contraindications, or intolerance to any of the study drugs including ACEis, ARBs, or sacubitril Patient with a known history of angioedema related to previous ACEi or ARB therapy; 4. eGFR 5.4 mEq/L; 6. ACS, stroke, TIA within the past month; 7. Primary cause of dyspnea due to non-cardiac, non-HF causes such as acute or chronic respiratory disorders; 8. History of heart transplant, currently on the transplant list, or with an left ventricular device; 9. Isolated right HF due to severe pulmonary disease; 10. Documented untreated ventricular arrhythmia with syncopal episodes within the past 3 months; 11. Symptomatic bradycardia or second- or third-degree heart block without a pacemaker; 12. Presence of hemodynamically significant mitral, aortic, or hypertrophic obstructive cardiomyopathy; 13. History of malignancy or any organ system (other than localized and resectable skin cancers) within the past year with a life expectancy of less than 1 year; 14. Known hepatic impairment (ALT or AST>3 times normal levels) or history of cirrhosis with evidence of portal hypertension (eg, presence of esophageal varices); 15. Pregnant or nursing (lactating) women; 16. Diagnosis of cardiomyopathy caused by perinatal or chemotherapy within 12 months; 17. Any surgical or health condition that may significantly alter the characteristics of absorption, distribution, metabolism or excretion of the drug; 18. Bilateral renal artery stenosis is known or suspected.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| death from cardiovascular causes;rehospitalization for heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| death from any causes;rehospitalization for any causes; | — |
Countries
China
Contacts
Public ContactYun He
Chongqing Kanghua Zhonglian Cardiovascular Hospital
Outcome results
None listed