Effect of Angiotensin-Neprilysin Inhibition (ARNI) on Prognosis of Chronic Heart Failure

  • STATUS
    Recruiting
  • days left to enroll
    14
  • participants needed
    340
  • sponsor
    First Affiliated Hospital Xi'an Jiaotong University
Updated on 23 January 2021
nt-probnp
ace inhibitor
angiotensin
enalapril
entresto
angiotensin ii receptor antagonist

Summary

This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers (ACEI/ARB) group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment.

Description

Chronic heart failure is associated with poor prognosis in cardiac patients, although systemic effective drugs has been applied in these patients. European Society of Cardiology (ESC) has recommended ARNI Sacubitril/Valsartan as first-line drugs in replacement of ACEI (I, B) in 2016 for these patients. While American College of Cardiology and The American Heart Association (ACC/AHA) made a first-line recommendation that patients with heart failure due to reduced ejection fraction (HFrEF) could be administrated ARNI directly. Hence, we apply this trial to find if ARNI could replace ACEI/ARB to provide insights for better treatment of chronic heart failure in China. This study is a randomized controlled multicenter clinical trial, in which about 340 patients with newly diagnosed or prior diagnosed chronic heart will be recruited. Patients will be randomly divided into Angiotensin-Neprilysin Inhibition (ARNI) group and ACEI/ARB group. All-cause death, cardiac death and re-hospitalization due to heart failure will be evaluated in 1, 3, 6, 12 months after recruitment. Other safety assessment including left ventricular ejection fraction (LVEF), 6 minutes walk test will be followed up as well.

Details
Condition Chronic Heart Failure
Treatment Entresto, ACEI/ARB
Clinical Study IdentifierNCT03821701
SponsorFirst Affiliated Hospital Xi'an Jiaotong University
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18
HFrEF, defined as LVEF40% and New York Heart Association (NYHA) class II
Plasma NT-proBNP 600 pg/ml, or NT-proBNP 400 pg/ml if patients have been hospitalized for heart failure in 12 months
If patients have been taking ACEI/ARB at recruitment, a stable dose equivalent to at least 10mg/day of enalapril will be required
Volunteer for the study and sign the informed consent

Exclusion Criteria

Symptomatic hypotension, systolic blood pressure < 95 mmHg at baseline
eGFR < 30 ml(/min1.73m2) at baseline
Serum potassium > 5.4 mmol/L at baseline
Contraindication of ACEI or ARB
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