Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction

Overview

Studies have demonstrated that the early initiation of ACEI/ARB to patients with acute myocardial infarction is beneficial, especially in patients combined with reduced LVEF or mild-moderate heart failure. Therefore, ACEI/ARB is a traditional treatment for patients post-infarction. Recent clinical trials have demonstrated that Sacubitril/Valsartan is more beneficial than Ramipril to patients post-PCI.Besides, Sacubitril/Valsartan is also effective for essential hypertension.This study aims to assess the effect of Sacubitril/Valsartan on short-term prognosis in hypertensive patients with acute myocardial infarction compared against Valsartan.

Full Title of Study: “The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2022

Interventions

  • Drug: Sacubitril/Valsartan 49/51mg/Tab
    • patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
  • Drug: Valsartan 80mg/Tab
    • Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.

Arms, Groups and Cohorts

  • Experimental: Sacubitril/Valsartan
    • Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
  • Active Comparator: Valsartan
    • 1 tablet of Valsartan every 24 hours for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Rate of MACE events no.1 by phone calls and questionnaires
    • Time Frame: 6 months
    • To assess the rate of myocardial infarction in post-infarction patients during the study follow-up.
  • Rate of MACE events No.2 by phone calls and questionnaires
    • Time Frame: 6 months
    • To assess the rate of stroke in patients post-MI during the follow up period
  • Rate of MACE events No.3 phone calls and questionnaires
    • Time Frame: 6 months
    • To assess the rate of death from cardiovascular causes during the follow up time

Secondary Measures

  • Left ventricular ejection fraction(LVEF) by echocardiography
    • Time Frame: 6 months
    • Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment.
  • Rate of post infarction angina by following up in the clinic
    • Time Frame: 6 months
    • Evaluate the Effect of Sacubitril/Valsartan versus Valsartan on the development of post-infarction angina.
  • The rate of heart failure occurrence by following up in the clinic
    • Time Frame: 6 months
    • Assess the occurence of heart failure during the study follow-up.
  • Left ventricular end-diastolic volume(LVEDV) by echocardiography
    • Time Frame: 6 months
    • Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography

Participating in This Clinical Trial

Inclusion Criteria

1. Diagnosed with new-onset MI, either STEMI or NSTEMI, according to the fourth universal definition of MI (Thygesen et al. 2019), disease onset within 7 days. 2. Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension. 3. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol. Exclusion Criteria:

1. Patients with severe renal dysfunction. (GFR<60mmol/L). 2. Patients who have recently undergone immunosuppressive therapy. 3. Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan. 4. Patients who are hemodynamically unstable. 5. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %). 6. Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial. 7. Any non-CV condition, such as active malignancy requiring treatment at the time of screening, or severe diseases with a life expectancy of fewer than two years based on the investigator´s clinical judgment. 8. Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Qingdao Central Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jun Teng, MD, Study Director, Qingdao Central Hospital
  • Overall Contact(s)
    • Mengmei Li, MD, 0086053284961672, sjogen@163.com

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