Program of Angiotensin-Neprilysin Inhibition in Admitted Patients With Worsening Heart Failure (PREMIER)

  • STATUS
    Recruiting
  • End date
    Mar 3, 2025
  • participants needed
    400
  • sponsor
    WDB Clinical Research Co., Ltd.
Updated on 5 January 2022
edema
ejection fraction
heart failure
dyspnea
nt-probnp
congestion
b-type natriuretic peptide
ace inhibitor
natriuretic peptide
vasodilator
angiotensin
valsartan
inotropic agent
angiotensin ii receptor antagonists

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.

Description

The high rate of rehospitalization and mortality of patients hospitalized for acute exacerbation of HF, especially at the early phase after discharge, has long been a serious clinical concern. However, few trials evaluating drug therapies on the post-acute phase of HF showed positive and/or satisfying results. Therefore, it is urgently required to establish an efficient treatment strategy at that phase. Sacubitril valsartan is an angiotensin receptor-neprilysin inhibitor that was approved in Japan in 2020 for patients who are taking standard care of HF.

In this investigator-initiated, multicenter, 8-week, randomized controlled study (PREMIER), the investigators try to assess the effect of in-hospital initiation of sacubitril valsartan, compared to standard HF treatment, in patients who were admitted due to worsening heart failure, on the NT-proBNP concentrations.

Details
Condition Heart Failure
Treatment Standard Treatment, Sacubitril Valsartan Sodium Hydrate, Sacubitril Valsartan Sodium Hydrate
Clinical Study IdentifierNCT05164653
SponsorWDB Clinical Research Co., Ltd.
Last Modified on5 January 2022

Eligibility

Yes No Not Sure

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
NT-proBNP ≥1200 pg/mL or BNP ≥300 pg/mL

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
History of angioedema
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
Serum potassium ≥5.3 mEq/L or more
Cardiogenic shock
On cardiopulmonary support, with a left ventricular assist device, or on a ventilator
Onset of stroke or acute coronary syndrome within 30 days prior to randomization
History of surgical or percutaneous treatment of cardiovascular disease within 30 days prior to randomization
Patients with an advanced plan for surgical or percutaneous treatment of cardiovascular disease or for coronary artery revascularization during an observation period
Patients with an advanced plan for pacemaker implantation, cardiac resynchronization therapy, or electrical cardioversion during an observation period
History or comorbidity of hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy such as amyloidosis or sarcoidosis
Active pericardial disease
History of or awaiting heart transplant
Severe chronic respiratory disease or active infectious disease
Patients who are or might become pregnant or who are breastfeeding
Patients whom a study investigator determined to be unsuitable for the study (such as patients with comorbid active malignancy)
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