Program of Angiotensin-Neprilysin Inhibition in Admitted Patients With Worsening Heart Failure (P… (NCT05164653) | Clinical Trial Compass
Active — Not RecruitingPhase 4
Program of Angiotensin-Neprilysin Inhibition in Admitted Patients With Worsening Heart Failure (PREMIER)
Japan400 participantsStarted 2021-12-27
Plain-language summary
The aim of this study is to assess the treatment effect of sacubitril valsartan versus conventional therapy for heart failure (HF) in admitted patients due to exacerbation of HF on the N-terminal fragment of pro-B-type natriuretic peptide (NT-proBNP) concentrations.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. Patients must provide written informed consent themselves to participate in this study
✓. Aged 20 or older at consent (male or female)
✓. 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)
✓. NYHA class II-IV
✓. Taking an ACE inhibitor or an ARB
✓. Can undergo randomization within 7 days of current hospitalization
✓. 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
✓. Patients who meet the following reference range for natriuretic peptide level from 48 hours before current hospitalization to the time of eligibility determination
Exclusion criteria
✕. Currently taking oral sacubitril valsartan or have taken it within 30 days prior to randomization
✕. 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
✕
What they're measuring
1
Proportional change in NT-proBNP concentrations from baseline to 8 weeks
✕. Severe renal dysfunction (\<eGFR 30 mL/min/1.73 m\^2), on maintenance dialysis, or known bilateral renal artery stenosis (in patients with solitary kidney, known renal artery stenosis in the residual kidney)
✕. Severe liver dysfunction (Child-Pugh class C)
✕. Diabetic patients who are currently taking aliskiren fumarate