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

Hypertension Clinical Trial

Official title:

The Effect of Sacubitril/Valsartan Versus Valsartan on the Short-term Prognosis of Hypertensive Patients With Acute Myocardial Infarction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05060588
• Other study ID #: Sacu-HPT
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2021
• Est. completion date: February 2023

Study information

• Verified date: September 2021
• Source: Qingdao Central Hospital
• Contact: Mengmei Li, MD
• Phone: 0086053284961672
• Email: sjogen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 2023
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Infarction
• Myocardial Infarction

Intervention

Drug:
• Sacubitril/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
• Valsartan 80mg/Tab
Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.

Locations

Country	Name	City	State
China	Mengmei Li	Qingdao	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qingdao Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of MACE events no.1 by phone calls and questionnaires	To assess the rate of myocardial infarction in post-infarction patients during the study follow-up.	6 months
Primary	Rate of MACE events No.2 by phone calls and questionnaires	To assess the rate of stroke in patients post-MI during the follow up period	6 months
Primary	Rate of MACE events No.3 phone calls and questionnaires	To assess the rate of death from cardiovascular causes during the follow up time	6 months
Secondary	Left ventricular ejection fraction(LVEF) by echocardiography	Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment.	6 months
Secondary	Rate of post infarction angina by following up in the clinic	Evaluate the Effect of Sacubitril/Valsartan versus Valsartan on the development of post-infarction angina.	6 months
Secondary	The rate of heart failure occurrence by following up in the clinic	Assess the occurence of heart failure during the study follow-up.	6 months
Secondary	Left ventricular end-diastolic volume(LVEDV) by echocardiography	Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography	6 months