Worsening heart failure with both signs of congestion and symptoms of heart failure
Conditions
Interventions
Participants will be randomized within 7 days of admission to either the sacubitril valsartan group or the control group (no sacubitril valsartan group). They will then begin protocol treatment during
Sponsors
Node Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Patients must provide written informed consent themselves to participate in this study 2)Aged 20 or older at consent (male or female) 3)Hospitalized due to worsening heart failure with both signs of congestion (such as edema, moist rales, and congestion on chest X-ray) and symptoms of heart failure (such as dyspnea on mild exertion or at rest) (any level of left ventricular ejection fraction) 4)NYHA class II-IV 5)Taking an ACE inhibitor or an ARB 6)Can undergo randomization within 7 days of current hospitalization 7)Patients who meet the following criteria of hemodynamic stability I.Systolic blood pressure >100 mm Hg II.No dose increase of intravenous diuretic within 6 hours before randomization III.No intravenous administration of vasodilator (such as carperitide or nitrates) or positive inotropic agent 8)Patients who meet the following reference range for natriuretic peptide level from 48 hours before current hospitalization to the time of eligibility determination NT-proBNP >-1200 pg/mL or BNP >-300 pg/mL
Exclusion criteria
Exclusion criteria: 1)Currently taking oral sacubitril valsartan or have taken it within 30 days prior to randomization 2)History of hypersensitivity to ingredients in ARB, ACE inhibitor, or sacubitril valsartan; or expected to be contraindicated for or intolerant to any of these drugs 3)History of angioedema 4)Severe renal dysfunction (5.3 mEq/L or more 8)Cardiogenic shock 9)On cardiopulmonary support, with a left ventricular assist device, or on a ventilator 10)Onset of stroke or acute coronary syndrome within 30 days prior to randomization 11)History of surgical or percutaneous treatment of cardiovascular disease within 30 days prior to randomization 12)Patients with an advanced plan for surgical or percutaneous treatment of cardiovascular disease or for coronary artery revascularization during an observation period 13)Patients with an advanced plan for pacemaker implantation, cardiac resynchronization therapy, or electrical cardioversion during an observation period 14)History or comorbidity of hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy such as amyloidosis or sarcoidosis 15)Active pericardial disease 16)History of or awaiting heart transplant 17)Severe chronic respiratory disease or active infectious disease 18)Patients who are or might become pregnant or who are breastfeeding 19)Patients whom a study investigator determined to be unsuitable for the study (such as patients with comorbid active malignancy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Group ratio of percent change in geometric mean NT-proBNP from baseline to 8 weeks after protocol treatment initiation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Group ratio of percent change in geometric mean NT-proBNP from baseline to 4 weeks after protocol treatment initiation 2.Percentage of patients with at least a 50% reduction in NT-proBNP levels at 8 weeks after protocol treatment initiation compared with baseline 3.Percentage of patients with at least a 30% reduction in NT-proBNP levels at 4 weeks after protocol treatment initiation compared with baseline 4.Percentage of patients with at least a 40% reduction from baseline in mean NT-proBNP at 4 and 8 weeks after protocol treatment initiation 5.Amount of change and percent change in cardiac troponin T, CRP, GDF-15, soluble ST2, glucoalbumin, and 1,5-AG at 8 weeks after protocol treatment initiation compared with baseline 6.Amount of change and percent change in weight, BMI, blood pressure, heart rate, clinical laboratory test values, and NYHA class at 4 and 8 weeks after protocol treatment initiation compared with baseline 7.Amount of change and percent change in echocardiographic indices of cardiac function (LVEDV, LVESV, LVEF, septal e', lateral e', flow velocity pattern through the mitral orifice (E), E/e', LVMI, LAVI, LVOT, LVOT-VTI, TR velocity, IVC diameter, GLS, and left atrial strain (2-chamber view and 4-chamber view)) and percentage of patients with at least a 50% respiratory variation in IVC diameter at 8 weeks after protocol treatment initiation compared with baseline 8.Amount of change in KCCQ-12 score and percentage of patients with at least a 5-point increase in score at 8 weeks after protocol treatment initiation compared with baseline 9.Time to first occurrences of the composite event of all-cause death or worsening heart failure event, defined as i) unplanned rehospitalization, ii) initiation of intravenous treatment (vasodilator or positive inotropic agent) for heart failure (during hospitalization: excludes at rehospitalization), iii) urgent visit due to heart failure requiring intravenous treatment (vasodilator, positive inotropic agent, or d | — |
Contacts
Public ContactAtsushi Tanaka
Saga University Hospital
Outcome results
None listed