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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 : 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

Tracking Information
First Submitted Date  ICMJE January 27, 2019
First Posted Date  ICMJE January 30, 2019
Last Update Posted Date August 7, 2019
Actual Study Start Date  ICMJE June 1, 2018
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2019)
  • Six-minutes walking test [ Time Frame: Test in 1, 3, 6, 12 months comparing to the baseline. ]
    A test evaluating cardiac function.
  • LVEF [ Time Frame: Test in 1, 3, 6, 12 months comparing to the baseline. ]
    Left ventricular ejection fraction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Angiotensin-Neprilysin Inhibition (ARNI) on Prognosis of Chronic Heart Failure
Official Title  ICMJE A Multicenter, Randomized Controlled Trial of Angiotensin-Neprilysin Inhibition (ARNI) in the Chronic Heart Failure
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chronic Heart Failure
Intervention  ICMJE
  • Drug: Entresto
    Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study
  • Drug: ACEI/ARB
    Choose one of ACEI/ARB according to the clinical condition among the whole study.
Study Arms  ICMJE
  • Experimental: Newly diagnosed HFrEF ARNI
    Newly diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.
    Intervention: Drug: Entresto
  • 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.
    Intervention: Drug: ACEI/ARB
  • Experimental: Prior diagnosed HFrEF ARNI
    Prior diagnosed HFrEF patients will be administered ARNI Entresto according to the clinical condition among the whole study.
    Intervention: Drug: Entresto
  • 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.
    Intervention: Drug: ACEI/ARB
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 28, 2019)
340
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2022
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yihui Xiao +86 13572236467 ext +8613572236467 sbw_514@163.com
Contact: Yihui Xiao +8613572236467 ext +8613572236467 sbw_514@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03821701
Other Study ID Numbers  ICMJE XJTU1AF-CRF-2018-019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party First Affiliated Hospital Xi'an Jiaotong University
Study Sponsor  ICMJE First Affiliated Hospital Xi'an Jiaotong University
Collaborators  ICMJE
  • Baoji Central Hospital
  • First Affiliated Hospital Xi'an Medical University
Investigators  ICMJE
Study Director: Yihui Xiao First Affiliated Hospital Xi'an Jiaotong University
PRS Account First Affiliated Hospital Xi'an Jiaotong University
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP