NCT03821701

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
340

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2022

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

2.7 years

First QC Date

January 27, 2019

Last Update Submit

August 5, 2019

Conditions

Chronic Heart Failure

Keywords

Shakurba valsartanHeart failureACEI/ARB

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Six-minutes walking test

    Test in 1, 3, 6, 12 months comparing to the baseline.

  • LVEF

    Test in 1, 3, 6, 12 months comparing to the baseline.

Study Arms (4)

Newly diagnosed HFrEF ARNI

EXPERIMENTAL

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

Drug: Entresto

Newly diagnosed HFrEF ACEI/ARB

ACTIVE COMPARATOR

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

Drug: ACEI/ARB

Prior diagnosed HFrEF ARNI

EXPERIMENTAL

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

Drug: Entresto

Prior diagnosed HFrEF ACEI/ARB

ACTIVE COMPARATOR

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

Drug: ACEI/ARB

Interventions

EntrestoDRUG

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

Newly diagnosed HFrEF ARNIPrior diagnosed HFrEF ARNI
ACEI/ARBDRUG

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

Newly diagnosed HFrEF ACEI/ARBPrior diagnosed HFrEF ACEI/ARB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Yihui Xiao

    First Affiliated Hospital Xi'an Jiaotong University

    STUDY DIRECTOR

Central Study Contacts

Yihui Xiao

CONTACT

+86 13572236467sbw_514@163.com

Yihui Xiao

CONTACT

+8613572236467sbw_514@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2019

First Posted

January 30, 2019

Study Start

June 1, 2018

Primary Completion

January 31, 2021

Study Completion

January 31, 2022

Last Updated

August 7, 2019

Record last verified: 2019-08

Locations

CN(1)