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

NCT05060588 | Unknown Phase 4

• 1 other identifier: Sacu-HPT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myocardial Infarction; Hypertension

Keywords

Sacubitril/Valsartan; Valsartan; Myocardial Infarction; Hypertension

Outcome Measures

Primary Outcomes (3)

• Rate of MACE events no.1 by phone calls and questionnaires

  To assess the rate of myocardial infarction in post-infarction patients during the study follow-up.

  6 months

• Rate of MACE events No.2 by phone calls and questionnaires

  To assess the rate of stroke in patients post-MI during the follow up period

  6 months

• Rate of MACE events No.3 phone calls and questionnaires

  To assess the rate of death from cardiovascular causes during the follow up time

  6 months

Secondary Outcomes (4)

• Left ventricular ejection fraction(LVEF) by echocardiography

  6 months

• Rate of post infarction angina by following up in the clinic

  6 months

• The rate of heart failure occurrence by following up in the clinic

  6 months

• Left ventricular end-diastolic volume(LVEDV) by echocardiography

  6 months

Study Arms (2)

Sacubitril/Valsartan

EXPERIMENTAL

Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months

Drug: Sacubitril/Valsartan 49/51mg/Tab

Valsartan

ACTIVE COMPARATOR

1 tablet of Valsartan every 24 hours for 6 months

Drug: Valsartan 80mg/Tab

Interventions

Sacubitril/Valsartan 49/51mg/Tab DRUG

patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months

Also known as: Sacubitril/Valsartan Group

Sacubitril/Valsartan

Valsartan 80mg/Tab DRUG

Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.

Also known as: Valsartan Group

Valsartan

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension.
• Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and the protocol.

You may not qualify if:

• Patients with severe renal dysfunction. (GFR\<60mmol/L).
• Patients who have recently undergone immunosuppressive therapy.
• Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan.
• Patients who are hemodynamically unstable.
• Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %).
• 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.
• Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Sponsors & Collaborators

• Qingdao Central Hospital: lead

Study Sites (1)

Mengmei Li

Qingdao, Shandong, 266042, China

Location

MeSH Terms

Conditions

Myocardial Infarction; Hypertension

Interventions

sacubitril; Valsartan

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Jun Teng, MD

  Qingdao Central Hospital

  STUDY DIRECTOR

Central Study Contacts

Mengmei Li, MD

CONTACT

0086053284961672; sjogen@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 29, 2021
• Study Start: October 1, 2021
• Primary Completion: October 1, 2022
• Study Completion: February 1, 2023
• Last Updated: September 29, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)