The Role of Sacubitril/Valsartan in Post-acute Myocardial Infarction

NCT ID: NCT03893435

Last Updated: 2022-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2022-10-01

Brief Summary

Sacubitril/Valsartan (SAC/VAL) is a new treatment of congestive heart failure (CHF) recently indicated as class I, level of evidence B in the recent European Society of Cardiology (ESC) guidelines 2016 of CHF. PARADIGM-HF trial demonstrated a significant improvement of morbidity and mortality with SAC/VAL in comparison to enalapril. So far, no data available about the effect of usage of SAC/VAL post-acute myocardial infarction (AMI) except in animal experimental models.

The purpose of the research is evaluation of the effects of SAC/VAL in post-AMI in comparison to the traditional Angiotensin Converting Enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in a real-life clinical trial in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.

Detailed Description

Background and study rationale:

Sacubitril/Valsartan (SAC/VAL) is now approved by the U.S. Food and Drug Administration (FDA) for heart failure with reduced ejection fraction (HFrEF) and also, recently indicated as class I indication, level of evidence B in the European Society of Cardiology (ESC) guidelines 2016 on congestive heart failure (CHF).(1) PARADIGM-HF trial demonstrated that morbidity and mortality can be improved with SAC/VAL In comparison to enalapril, it reduced the occurrence of cardiovascular death or hospitalization for CHF by 20% with a 16% reduction in all-cause mortality.(2) So far, no available data about the effect of usage of SAC/VAL in post-AMI except in animal experimental models that proved efficacy of SAC/VAL in preventing AMI-induced LV dysfunction compared with SAC/VAL, also significantly attenuated LV scar size following AMI compared with placebo .(3)

Aim of the work:

• This study aims to investigate the effects of SAC/VAL in post-AMI through using it instead of conventional Angiotensin Converting enzyme inhibitors (ACEs inhibitors) or Angiotensin II Receptor Blockers (ARBs) in treatment of post-AMI patients with reduced left ventricular (LV) systolic function.
• Design: Randomized open label interventional clinical trial.

Conditions

Acute Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sacubitril/Valsartan

In successfully revascularized post-AMI patients with LVEF ≤40% Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.

Group Type: EXPERIMENTAL

Sacubitril / Valsartan Oral Tablet [Entresto]

Intervention Type: DRUG

Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.

Valsartan

In successfully revascularized post-AMI patients with LVEF ≤40% Valsartan with an initial dose of 40 mg PO BID, with subsequent titrations to target maintenance dose of 160 mg BID as tolerated.

Group Type: ACTIVE_COMPARATOR

Sacubitril / Valsartan Oral Tablet [Entresto]

Intervention Type: DRUG

Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.

Interventions

Sacubitril / Valsartan Oral Tablet [Entresto]

Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.

Intervention Type: DRUG

Other Intervention Names

ARNI

Eligibility Criteria

Inclusion Criteria

• Post-AMI patients who underwent successful PPCI and LVEF ≤40%.

Exclusion Criteria

• Post-AMI patients who underwent successful PPCI and LVEF >40%.
• History of hypersensitivity or allergy to any of the study drugs, as well as known or suspected contraindications to the study drugs.
• Symptomatic hypotension and/or an SBP < 100 mmHg.
• Estimated GFR < 30 mL/min/1.73m2 as measured by the simplified MDRD formula or serum potassium > 5.2 mmol/L.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Young Investigator Group of Cardiovascular Research

NETWORK

Sponsor Role: lead

Responsible Party

Abdallah Almaghraby

Senior Registrar of Cardiology and Angiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sherif S Elbeltagui, MD

Role: STUDY_DIRECTOR

Assisstant Professor of Cardiology, University of Alexandria, Egypt

Locations

Andalusia Hospitals

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

YIG01201902

Identifier Type: -

Identifier Source: org_study_id