Chronic Heart Failure With Reduced Ejection Fraction
Conditions
Brief 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)
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
Sponsors
Shenzhen People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, positive drug parallel control, multicenter
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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）. | the end of 28th week | Left ventricular ejection fraction (LVEF) changed from baseline at the end of 28th week,Normal result value 50-70%. |
Countries
China
Contacts
Primary Contactjunbo he
Outcome results
None listed