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Effect of sacubitril/valsartan and ACEI/ARB on left ventricular remodeling in patients with STEMI after PCI: a prospective, superiority randomized controlled trial

Effect of sacubitril/valsartan and ACEI/ARB on left ventricular remodeling in patients with STEMI after PCI: a prospective, superiority randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115657
Enrollment
Unknown
Registered
2025-12-29
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

STEMI

Interventions

if ACEI intolerance occurs, valsartan may be used.
Test group (randomized): Sacubitril/Valsartan:The experimental group was administered sacubitril valsartan.
Control group (randomized): ACEI/ARB:The control group received benazepril

Sponsors

General Hospital of the Northern Theater Command, People's Liberation Army, No.83 Wenhua Road, Shenhe District, Shenyang City, Liaoning Province
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Must meet all the following criteria: 1) Age >= 18 years; 2) Patients with acute ST-segment elevation myocardial infarction (STEMI) who have their first episode and successfully undergo interventional therapy within 48 hours after onset. 3) Successful complete revascularization was achieved. (Definition of successful revascularization requires: (a) reduction of the minimum stenotic diameter of the culprit vessel to 20%; (b) treatment of all lesions with stenosis >= 70%; (c) TIMI grade 3 flow as assessed by angiography.) 4) Echocardiographic evaluation confirmed a left ventricular ejection fraction (LVEF) >= 40%; 5) Hemodynamic stability, defined as meeting the following criteria: For patients who received ACEI/ARB therapy within the past 24 hours, systolic blood pressure (SBP) >= 100 mmHg; For patients not receiving ACEI/ARB therapy, systolic blood pressure (SBP) >= 110 mmHg; Did not add intravenous diuretics or vasodilators; Has not used vasopressin and/or positive inotropic drugs within the past 24 hours. 6) Voluntary signing of the informed consent form.

Exclusion criteria

Exclusion criteria: Meets one of the following criteria: 1) Severe heart failure (NYHA Class IV, requiring intravenous positive inotropic drug support); 2) History of traumatic cerebral infarction, myocardial infarction, or previous revascularization procedures (including PCI, PTCA, CABG, implantation of ventricular assist devices, or heart transplantation); 3) Patients with left ventricular systolic dysfunction, cardiomyopathy (idiopathic hypertrophic cardiomyopathy, myocarditis, pericarditis, or active infection, etc.), primary valvular heart disease (moderate to severe), congenital heart disease, or those scheduled for cardiac surgery within 3 months; 4) Severe hepatic insufficiency (alanine aminotransferase (ALT) or aspartate aminotransferase (AST)> 3 times the upper limit of normal); 5) History of chronic renal impairment or eGFR 5.5 mmol/L); 6) Allergy or contraindication to the drugs used in this study; 7) The myocardial infarction (MI) location is acute inferior wall with right ventricular involvement, or acute inferior wall MI with right ventricular involvement. 8) Known to have malignant tumors or severe progressive diseases (e.g., active autoimmune disease, acute paroxysmal asthma/chronic obstructive pulmonary disease, or severe infections), with a projected survival period <12 months 9) Severe anemia (hemoglobin <10 g/dL) or platelet count <100×10^9/L; 10) Women who are pregnant or breastfeeding, or who plan to become pregnant; 11) Death during hospitalization; 12) Mental disorders, alcohol or drug abuse; 13) History of angioedema associated with prior ACEI/ARB therapy; 14) Lack of willingness for interventional therapy or poor compliance with anticipated clinical studies; 15) Participation in other ongoing clinical studies or any circumstances where the investigator deems the individual unsuitable for this study.

Design outcomes

Primary

MeasureTime frame
LVESV;LVEDV;

Secondary

MeasureTime frame
NT- proBNP;

Countries

China

Contacts

Public Contactwangxiaozeng

General Hospital of the Northern Theater Command of the Chinese People's Liberation Army

L1789280441@163.com+86 24 2885 6577

Outcome results

None listed

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