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

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ClinicalTrials.gov Identifier: NCT03821701
Recruitment Status : Unknown
Verified August 2019 by First Affiliated Hospital Xi'an Jiaotong University.
Recruitment status was:  Recruiting
First Posted : January 30, 2019
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
Baoji Central Hospital
First Affiliated Hospital Xi'an Medical University
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Drug: Entresto Drug: ACEI/ARB Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 340 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized Controlled Trial of Angiotensin-Neprilysin Inhibition (ARNI) in the Chronic Heart Failure
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Six-minutes walking test [ Time Frame: Test in 1, 3, 6, 12 months comparing to the baseline. ]
    A test evaluating cardiac function.

  2. LVEF [ Time Frame: Test in 1, 3, 6, 12 months comparing to the baseline. ]
    Left ventricular ejection fraction.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821701


Contacts
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Contact: Yihui Xiao +86 13572236467 ext +8613572236467 sbw_514@163.com
Contact: Yihui Xiao +8613572236467 ext +8613572236467 sbw_514@163.com

Locations
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China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710000
Contact: Yihui Xiao    +8613572236467    sbw_514@163.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Baoji Central Hospital
First Affiliated Hospital Xi'an Medical University
Investigators
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Study Director: Yihui Xiao First Affiliated Hospital Xi'an Jiaotong University
More Information
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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03821701    
Other Study ID Numbers: XJTU1AF-CRF-2018-019
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Shakurba valsartan
Heart failure
ACEI/ARB
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
 Sacubitril and valsartan sodium hydrate drug combination
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action