Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05553886

S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Led by Shenzhen People's Hospital · Updated on 2022-11-03

5

Participants Needed

1

Research Sites

262 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A randomized, double-blind, positive-drug parallel controlled, multicenter phase III trial of the efficacy and safety of S086 tablets in patients with chronic heart failure with reduced ejection fraction (HFrEF)

CONDITIONS

Official Title

S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with chronic heart failure (NYHA grade II-III) with reduced ejection fraction (LVEF 60;40%) and elevated BNP
  • Patients on a stable dose of heart failure treatment with no dose changes for at least 4 weeks before screening
  • Volunteers willing to participate and provide informed consent
Not Eligible

You will not qualify if you...

  • Previous continuous use of sacubitril valsartan sodium 150mg twice daily or more for over 3 months
  • Use of other study drugs or medical devices within 1 day, 30 days, or 5 half-lives before the visit
  • Known or suspected allergy to S086, sacubitril valsartan sodium, ARB, ACEI, or enkephin inhibitor (NEPI), or contraindications to sacubitril valsartan sodium
  • History of intolerance to the recommended target dose of ACEI or ARB
  • History of angioedema
  • Acute coronary syndrome within 6 weeks before the visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shenzhen People' S Hospital

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

J

junbo he

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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