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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Chronic Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Newly diagnosed HFrEF ARNI

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

Group Type EXPERIMENTAL

Entresto

Intervention Type DRUG

Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study

Newly diagnosed HFrEF ACEI/ARB

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

Group Type ACTIVE_COMPARATOR

ACEI/ARB

Intervention Type DRUG

Choose one of ACEI/ARB according to the clinical condition among the whole study.

Prior diagnosed HFrEF ARNI

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

Group Type EXPERIMENTAL

Entresto

Intervention Type DRUG

Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study

Prior diagnosed HFrEF ACEI/ARB

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

Group Type ACTIVE_COMPARATOR

ACEI/ARB

Intervention Type DRUG

Choose one of ACEI/ARB according to the clinical condition among the whole study.

Interventions

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Entresto

Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study

Intervention Type DRUG

ACEI/ARB

Choose one of ACEI/ARB according to the clinical condition among the whole study.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No