Advanced HF
Conditions
Interventions
Group 2:sacubitril/valsartan(LCZ696) group
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) outpatients and hospitalized patients with advanced heart failure in the first affiliated hospital of zhengzhou university shall be diagnosed according to the 2018 guidelines for heart failure; (2) agree to sign the informed consent; (3) aged 18 to 85 years old; (4) systolic pressure greater than or equal to 90 mmHg; (5) Severe symptoms of HF with dyspnea and/or fatigue at rest or with minimal exertion; (6) Episodes of fluid retention (pulmonary and/or systemic congestion, peripheral edema) and/or reduced cardiac output at rest (peripheral hypoperfusion); (7) Objective evidence of severe cardiac dysfunction shown by at least 1 of the following: LVEF 16 mm Hg and/or RAP >12 mm Hg by PA catheterization; High BNP or NT-proBNP plasma levels in the absence of noncardiac causes; (8) Severe impairment of functional capacity shown by 1 of the following: Inability to exercise; 6-Minute walk distance =300 m; Peak VO2 <12 to 14 mL/kg/min; (9) History of =1 HF hospitalization in past 6 months; (10) Presence of all the previous features despite attempts to optimize therapy, including diuretics and GDMT, unless these are poorly tolerated or contraindicated, and CRT when indicated.
Exclusion criteria
Exclusion criteria: (1) currently taking sacubitril/valsartan(LCZ696); (2) a history of hypersensitivity or intolerance to sacubitril/valsartan(LCZ696), ACEI or ARB, and contraindications known or suspected; (3) estimated glomerular filtration rate (eGFR) 5.5 mmol/L; (7) severe liver insufficiency (childs-pugh grade C); (8) changes in electrocardiogram (ECG) and myocardial necrosis markers (such as troponin) within 4 weeks of acute coronary syndrome, accompanied by corresponding symptoms (chest discomfort or angina pectoris); (9) PCI, coronary artery bypass grafting or biventricular pacing are planned or recently planned (less than 4 weeks); (10) currently hospitalized and awaiting organ transplantation; (11) pacemaker implantation is currently or planned within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| cardiac death;Rehospitalization due to heart failure; | — |
Secondary
| Measure | Time frame |
|---|---|
| all-cause mortality;left ventricular ejection fraction;Left atrial volume;left ventricular end-diastolic volume;Estimate pulmonary artery pressure;NT-ProBNP;cTNT/cTNI; | — |
Countries
China
Contacts
Public ContactDeliang Shen
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed