S086 tablets for treating 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)

This study is testing if S086 tablets can help people with chronic heart failure and reduced ejection fraction feel better compared to a standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenzhen People's Hospital (Academic / other)
• Locations: 1 site (Shenzhen, Guangdong)
• Trial ID: NCT05553886 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are patients with chronic heart failure (NYHA grade II-IV) and reduced ejection fraction (LVEF ≤ 40%) who have stable heart failure treatment.

Not a fit: Patients who have previously been treated with sacubitril valsartan sodium or have known allergies to the study drug may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing chronic heart failure with reduced ejection fraction.

How similar studies have performed: Other studies have shown success with similar approaches in treating chronic heart failure, making this trial a continuation of promising research.

Eligibility criteria

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 this trial is running

Shenzhen, Guangdong

• Shenzhen People' S Hospital — Shenzhen, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: junbo he

Conditions Chronic Heart Failure With Reduced Ejection Fraction