Hypertension, Myocardial Infarction
Conditions
Keywords
Sacubitril/Valsartan, Valsartan, Myocardial Infarction, Hypertension
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.
Interventions
DRUGSacubitril/Valsartan 49/51mg/Tab
patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
DRUGValsartan 80mg/Tab
Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.
Sponsors
Qingdao Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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.2 by phone calls and questionnaires | 6 months | To assess the rate of stroke in patients post-MI during the follow up period |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
Primary ContactMengmei Li, MD
Outcome results
None listed