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Clinical study for the efficacy and safety of Sacubitril/Valsartan in the treatment of acute decompensated heart failure

Clinical study for the efficacy and safety of Sacubitril/Valsartan in the treatment of acute decompensated heart failure

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030460
Enrollment
Unknown
Registered
2020-03-02
Start date
2017-10-30
Completion date
Unknown
Last updated
2020-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute decompensated heart failure

Interventions

Experimental group (sacubitril/valsartan) and control group (ACRI or ARB):sacubitril/valsartan

Sponsors

Department of Cardiology, The First Affiliated Hospital of Harbin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: Eligibility requirements included an age of 18 years or older, NYHA class III - IV, and an ejection fraction of 40% or less. Patients were required to have a B-type natriuretic peptide (BNP) level >=400 pg per milliliter or an N-terminal pro-BNP (NT-proBNP) level >=1600 pg per milliliter, a systolic blood pressure at least 100 mmHg, an estimated glomerular filtration rate (eGFR) >=30 mL/min per 1.73 m2 (calculated by the Modification of Diet in Renal Disease formula), and a potassium concentration =100 mm Hg with no need for intravenous diuretics during the prior 24 hours.

Exclusion criteria

Exclusion criteria: With a history of angioedema or other unacceptable side effects of ACEI or ARB, an allergy history of any ingredient of sacubitril/valsartan, occurrence of acute myocardial infarction in the previous month, being in perinatal period, presence of diseases that may seriously affect drug metabolism, or the patient's life expectancy less than 6 months.

Design outcomes

Primary

MeasureTime frame
death from any cause;

Secondary

MeasureTime frame
the readmission for HF;NYHA grade; 6-minute walk distance;

Countries

China

Contacts

Public ContactWeimin Li

Department of Cardiology, The First Affiliated Hospital of Harbin Medical University

liweimin_2009@163.com+86 13804601998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026