S086 tablets for treating chronic heart failure with reduced ejection fraction

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the efficacy and safety of S086 tablets in patients diagnosed with chronic heart failure with reduced ejection fraction (HFrEF). It is a randomized, double-blind, positive-drug parallel controlled study comparing S086 to a positive control drug. Participants must have stable doses of their underlying heart failure treatment for at least four weeks prior to screening. The trial aims to determine if S086 is noninferior to the control in managing HFrEF symptoms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with chronic heart failure (NYHA grade ⅱ-ⅳ) with reduced ejection fraction (LVEF≤40%) and elevated BNP were diagnosed 1a.
2. 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.
3. Volunteer to participate in the trial and sign an informed consent form 1c.

Exclusion Criteria:

1. Previous continuous administration of sacubitril valsartan sodium 150mg bid or more for more than 3 months 1a.
2. 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.
3. 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.
4. A previous history of intolerance to the recommended target dose of ACEI or ARB 1d.
5. He had a history of angioedema 1e.
6. Acute coronary syndrome occurred within 6 weeks before visit 1 1f.

Where it's running

• Shenzhen People' S Hospital
  Shenzhen, Guangdong, China Recruiting

Study contacts

• Study coordinator: junbo he
• Email: 527768709@qq.com
• Phone: 13434792084

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.