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

Qingdao Central Hospital

Status and phase: Unknown; Phase 4

Conditions: Hypertension; Myocardial Infarction

Treatments: Drug: Sacubitril/Valsartan 49/51mg/Tab; Drug: Valsartan 80mg/Tab

Study type: Interventional

Funder types: Other

Identifiers

NCT05060588

Sacu-HPT

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

Sacubitril/Valsartan

Experimental group

Description:

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

Treatment:

Drug: Sacubitril/Valsartan 49/51mg/Tab

Valsartan

Active Comparator group

Description:

1 tablet of Valsartan every 24 hours for 6 months

Treatment:

Drug: Valsartan 80mg/Tab