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

August 5, 2019 updated by: First Affiliated Hospital Xi'an Jiaotong University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

340

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yihui Xiao
  • Phone Number: +8613572236467 +86 13572236467
  • Email: sbw_514@163.com

Study Contact Backup

  • Name: Yihui Xiao
  • Phone Number: +8613572236467 +8613572236467
  • Email: sbw_514@163.com

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000
        • Recruiting
        • First Affiliated Hospital of Xi'an Jiaotong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Newly diagnosed HFrEF ARNI
Newly diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.
Drug: Entresto
Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study
Active Comparator: Newly diagnosed HFrEF ACEI/ARB
Newly diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study.
Drug: ACEI/ARB
Choose one of ACEI/ARB according to the clinical condition among the whole study.
Experimental: Prior diagnosed HFrEF ARNI
Prior diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.
Drug: Entresto
Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study
Active Comparator: Prior diagnosed HFrEF ACEI/ARB
Prior diagnosed HFrEF patients will be administered ACEI/ARB according to the clinical condition among the whole study.
Drug: ACEI/ARB
Choose one of ACEI/ARB according to the clinical condition among the whole study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular events
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Six-minutes walking test
Time Frame: Test in 1, 3, 6, 12 months comparing to the baseline.
A test evaluating cardiac function.
Test in 1, 3, 6, 12 months comparing to the baseline.
LVEF
Time Frame: Test in 1, 3, 6, 12 months comparing to the baseline.
Left ventricular ejection fraction.
Test in 1, 3, 6, 12 months comparing to the baseline.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Collaborators

Baoji Central Hospital
First Affiliated Hospital Xi'an Medical University

Investigators

  • Study Director: Yihui Xiao, First Affiliated Hospital Xi'an Jiaotong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

January 31, 2022

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

January 28, 2019

First Posted (Actual)

January 30, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 5, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJTU1AF-CRF-2018-019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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