RecruitingPhase 3NCT05553886

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)


Sponsor

Shenzhen People's Hospital

Enrollment

5 participants

Start Date

Dec 21, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new tablet called S086 in people with chronic heart failure whose heart pumps less blood than normal (reduced ejection fraction). Researchers want to see if it is safe and effective compared to existing treatments. **You may be eligible if:** - You have been diagnosed with chronic heart failure with reduced heart pumping function (ejection fraction of 40% or less) - Your heart failure symptoms are in NYHA class II to IV (moderate to severe) - Your treatment dose has been stable for at least 4 weeks - You are willing to participate and sign a consent form **You may NOT be eligible if:** - You have taken sacubitril/valsartan (a common heart failure drug) at high doses for more than 3 months - You are currently in another drug trial - You are allergic to any of the ingredients in S086 or similar drugs - You have had a history of angioedema (severe swelling) - You had an acute coronary event (like a heart attack) within the last 6 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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


Locations(1)

Shenzhen People' S Hospital

Shenzhen, Guangdong, China

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NCT05553886


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