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

Chronic Heart Failure Clinical Trial

Official title:

A Multicenter, Randomized Controlled Trial of Angiotensin-Neprilysin Inhibition (ARNI) in the Chronic Heart Failure

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821701
• Other study ID #: XJTU1AF-CRF-2018-019
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: August 2019
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Yihui Xiao
• Phone: +86 13572236467
• Email: sbw_514[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

Intervention

Drug:
• Entresto
Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study
• ACEI/ARB
Choose one of ACEI/ARB according to the clinical condition among the whole study.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (3)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University	Baoji Central Hospital, First Affiliated Hospital Xi'an Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular events	Composite outcomes of all-cause death including cardiac death and re-hospitalization due to heart failure	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
Secondary	Six-minutes walking test	A test evaluating cardiac function.	Test in 1, 3, 6, 12 months comparing to the baseline.
Secondary	LVEF	Left ventricular ejection fraction.	Test in 1, 3, 6, 12 months comparing to the baseline.