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

Phase 4

• Conditions: Myocardial Infarction; Hypertension
• Interventions: Drug: Valsartan 80mg/Tab; Drug: Sacubitril/Valsartan 49/51mg/Tab

• Registration Number: NCT05060588
• Lead Sponsor: Qingdao Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-09
• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-18
• Last Update Submitted: 2021-09-18
• Study First Posted: 2021-09-29
• Last Update Posted: 2021-09-29
• Study Start: 2021-10
• Primary Completion: 2022-10
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Valsartan	Valsartan 80mg/Tab	1 tablet of Valsartan every 24 hours for 6 months
Sacubitril/Valsartan	Sacubitril/Valsartan 49/51mg/Tab	Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mengmei Li; 🇨🇳 Qingdao, Shandong, China