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NCT Number: NCT05553886

S086 Tablets for Chronic Heart Failure With Reduced Ejection Fraction

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)

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shenzhen People' S Hospital

Shenzhen, Guangdong, 518000, China

Location status: Recruiting

Location contact

Jun Bo He

CONTACT

[email protected]

13434792084

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with chronic heart failure (NYHA grade ⅱ-ⅳ) with reduced ejection fraction (LVEF≤40%) and elevated BNP were diagnosed 1a.
  • Patients received a stable dose of the underlying treatment for heart failure, defined as no change in dose for at least 4 weeks before screening 1b.
  • Volunteer to participate in the trial and sign an informed consent form 1c.

Exclusion criteria

  • Previous continuous administration of sacubitril valsartan sodium 150mg bid or more for more than 3 months 1a.
  • Use of other study drugs or use of any study medical device within 1 day of the visit or within 30 days prior to the visit or within 5 half-lives of the drug, whichever is longer 1b.
  • Known or suspected allergy to S086, sacubitril valsartan sodium, ARB, ACEI, or enkephin inhibitor (NEPI), and known or suspected contraindications to sacubitril valsartan sodium 1c.
  • A previous history of intolerance to the recommended target dose of ACEI or ARB 1d.
  • He had a history of angioedema 1e.
  • Acute coronary syndrome occurred within 6 weeks before visit 1 1f.

Treatment and study plan

To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug

Drug

To evaluate whether the efficacy of the study drug is noninferior to that of the positive control drug

Primary outcomes

  1. Sacubitril valsartan sodium tablets (trade name: Nohintal) were used as a control to study the efficacy of S086 tablets in the treatment of Chronic heart failure with reduced ejection fraction(HFrEF).

    Time frame: the end of 28th week

    Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%.

Study contacts

Contact information is provided by the study sponsor or research team.

junbo he

CONTACT

[email protected]

13434792084

Sponsors and collaborators

Lead sponsor

Shenzhen People's Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Sep 23, 2022
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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