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

Sponsored by Qingdao Central Hospital

About this trial

Last updated 4 years ago

Study ID

Sacu-HPT

Status

Unknown status

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 2 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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.

Locations

Location

Status