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

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qingdao Central Hospital
• Treatments: Valsartan

Criteria

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.