Program of Angiotensin-Neprilysin Inhibition in Admitted Patients With Worsening Heart Failure (PREMIER)
- Conditions
- Heart Failure
- Registration Number
- NCT05164653
- Lead Sponsor
- Saga University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> 1. Patients must provide written informed consent themselves to participate in this<br> study<br><br> 2. Aged 20 or older at consent (male or female)<br><br> 3. Hospitalized due to worsening heart failure with both signs of congestion (such as<br> edema, moist rales, and congestion on chest X-ray) and symptoms of heart failure<br> (such as dyspnea on mild exertion or at rest) (any level of left ventricular<br> ejection fraction)<br><br> 4. NYHA class II-IV<br><br> 5. Taking an ACE inhibitor or an ARB<br><br> 6. Can undergo randomization within 7 days of current hospitalization<br><br> 7. Patients who meet the following criteria of hemodynamic stability I. Systolic blood<br> pressure =100 mm Hg II. No dose increase of intravenous diuretic within 6 hours<br> before randomization III. No intravenous administration of vasodilator (such as<br> carperitide or nitrates) or positive inotropic agent<br><br> 8. Patients who meet the following reference range for natriuretic peptide level from<br> 48 hours before current hospitalization to the time of eligibility determination<br><br>NT-proBNP =1200 pg/mL or BNP =300 pg/mL<br><br>Exclusion Criteria:<br><br> 1. Currently taking oral sacubitril valsartan or have taken it within 30 days prior to<br> randomization<br><br> 2. History of hypersensitivity to ingredients in ARB, ACE inhibitor, or sacubitril<br> valsartan; or expected to be contraindicated for or intolerant to any of these drugs<br><br> 3. History of angioedema<br><br> 4. Severe renal dysfunction (<eGFR 30 mL/min/1.73 m^2), on maintenance dialysis, or<br> known bilateral renal artery stenosis (in patients with solitary kidney, known renal<br> artery stenosis in the residual kidney)<br><br> 5. Severe liver dysfunction (Child-Pugh class C)<br><br> 6. Diabetic patients who are currently taking aliskiren fumarate<br><br> 7. Serum potassium =5.3 mEq/L or more<br><br> 8. Cardiogenic shock<br><br> 9. On cardiopulmonary support, with a left ventricular assist device, or on a<br> ventilator<br><br> 10. Onset of stroke or acute coronary syndrome within 30 days prior to randomization<br><br> 11. History of surgical or percutaneous treatment of cardiovascular disease within 30<br> days prior to randomization<br><br> 12. Patients with an advanced plan for surgical or percutaneous treatment of<br> cardiovascular disease or for coronary artery revascularization during an<br> observation period<br><br> 13. Patients with an advanced plan for pacemaker implantation, cardiac resynchronization<br> therapy, or electrical cardioversion during an observation period<br><br> 14. History or comorbidity of hypertrophic obstructive cardiomyopathy or infiltrative<br> cardiomyopathy such as amyloidosis or sarcoidosis<br><br> 15. Active pericardial disease<br><br> 16. History of or awaiting heart transplant<br><br> 17. Severe chronic respiratory disease or active infectious disease<br><br> 18. Patients who are or might become pregnant or who are breastfeeding<br><br> 19. Patients whom a study investigator determined to be unsuitable for the study (such<br> as patients with comorbid active malignancy)
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportional change in NT-proBNP concentrations from baseline to 8 weeks
- Secondary Outcome Measures
Name Time Method