Clinical trial NCT05060588: Sacubitril/Valsartan Versus Valsartan for Hypertensive Patients With Acute Myocardial Infarction
Official title: The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Myocardial Infarction
Hypertension
Keywords: Sacubitril/Valsartan
Valsartan
Myocardial Infarction
Hypertension
Lead sponsor: Qingdao Central Hospital
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Rate of MACE events no.1 by phone calls and questionnaires
timeFrame: 6 months
measure: Rate of MACE events No.2 by phone calls and questionnaires
timeFrame: 6 months
measure: Rate of MACE events No.3 phone calls and questionnaires
timeFrame: 6 months
Secondary outcomes:
measure: Left ventricular ejection fraction(LVEF) by echocardiography
timeFrame: 6 months
measure: Rate of post infarction angina by following up in the clinic
timeFrame: 6 months
measure: The rate of heart failure occurrence by following up in the clinic
timeFrame: 6 months
measure: Left ventricular end-diastolic volume(LVEDV) by echocardiography
timeFrame: 6 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Mengmei Li
state: Shandong
Study officials:
affiliation: Qingdao Central Hospital
name: Jun Teng, MD
role: STUDY_DIRECTOR
References: