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

Xi'an Jiaotong University

Status: Unknown

Conditions: Chronic Heart Failure

Treatments: Drug: ACEI/ARB; Drug: Entresto

Study type: Interventional

Funder types: Other

Identifiers

NCT03821701

XJTU1AF-CRF-2018-019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• HFrEF, defined as LVEF≤40% 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(/min*1.73m2) at baseline.
• Serum potassium > 5.4 mmol/L at baseline.
• Contraindication of ACEI or ARB.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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340 participants in 4 patient groups

Newly diagnosed HFrEF ARNI

Experimental group

Description:

Newly diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.

Treatment:

Drug: Entresto

Newly diagnosed HFrEF ACEI/ARB

Active Comparator group

Description:

Newly diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study.

Treatment:

Drug: ACEI/ARB

Prior diagnosed HFrEF ARNI

Experimental group

Description:

Prior diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.

Treatment:

Drug: Entresto

Prior diagnosed HFrEF ACEI/ARB

Active Comparator group

Description:

Prior diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study.

Treatment:

Drug: ACEI/ARB