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

Primary Purpose

Myocardial Infarction, Hypertension

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Sacubitril/Valsartan 49/51mg/Tab

Valsartan 80mg/Tab

About this trial

This is an interventional treatment trial for Myocardial Infarction focused on measuring Sacubitril/Valsartan, Valsartan, Myocardial Infarction, Hypertension

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension.
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:

Patients with severe renal dysfunction. (GFR<60mmol/L).
Patients who have recently undergone immunosuppressive therapy.
Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan.
Patients who are hemodynamically unstable.
Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %).
Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial.
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.
Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Sites / Locations

Mengmei Li

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sacubitril/Valsartan

Valsartan

Arm Description

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

1 tablet of Valsartan every 24 hours for 6 months

Outcomes

Primary Outcome Measures

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.

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

Rate of MACE events No.3 phone calls and questionnaires

To assess the rate of death from cardiovascular causes during the follow up time

Secondary Outcome Measures

Left ventricular ejection fraction(LVEF) by echocardiography

Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment.

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.

The rate of heart failure occurrence by following up in the clinic

Assess the occurence of heart failure during the study follow-up.

Left ventricular end-diastolic volume(LVEDV) by echocardiography

Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography

Full Information

NCT ID

NCT05060588

First Posted

September 13, 2021

Last Updated

September 18, 2021

Sponsor

Qingdao Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05060588

Brief Title

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

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 2021 (Anticipated)

Primary Completion Date

October 2022 (Anticipated)

Study Completion Date

February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Qingdao Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Infarction, Hypertension

Keywords

Sacubitril/Valsartan, Valsartan, Myocardial Infarction, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sacubitril/Valsartan

Arm Type

Experimental

Arm Description

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

Arm Title

Valsartan

Arm Type

Active Comparator

Arm Description

1 tablet of Valsartan every 24 hours for 6 months

Intervention Type

Drug

Intervention Name(s)

Sacubitril/Valsartan 49/51mg/Tab

Other Intervention Name(s)

Sacubitril/Valsartan Group

Intervention Description

patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months

Intervention Type

Drug

Intervention Name(s)

Valsartan 80mg/Tab

Other Intervention Name(s)

Valsartan Group

Intervention Description

Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.

Primary Outcome Measure Information:

Title

Rate of MACE events no.1 by phone calls and questionnaires

Description

To assess the rate of myocardial infarction in post-infarction patients during the study follow-up.

Time Frame

6 months

Title

Rate of MACE events No.2 by phone calls and questionnaires

Description

To assess the rate of stroke in patients post-MI during the follow up period

Time Frame

6 months

Title

Rate of MACE events No.3 phone calls and questionnaires

Description

To assess the rate of death from cardiovascular causes during the follow up time

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Left ventricular ejection fraction(LVEF) by echocardiography

Description

Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment.

Time Frame

6 months

Title

Rate of post infarction angina by following up in the clinic

Description

Evaluate the Effect of Sacubitril/Valsartan versus Valsartan on the development of post-infarction angina.

Time Frame

6 months

Title

The rate of heart failure occurrence by following up in the clinic

Description

Assess the occurence of heart failure during the study follow-up.

Time Frame

6 months

Title

Left ventricular end-diastolic volume(LVEDV) by echocardiography

Description

Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Patients are previously diagnosed with essential hypertension or newly diagnosed with essential hypertension. 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: Patients with severe renal dysfunction. (GFR<60mmol/L). Patients who have recently undergone immunosuppressive therapy. Patients who are known to be allergic to Sacubitril/Valsartan and Valsartan. Patients who are hemodynamically unstable. Chronic symptomatic heart failure within the last year and known reduced ejection fraction (LVEF≤40 %). Severe hepatic impairment (Child-Pugh class C) at the time of inclusion into the trial. 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. Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mengmei Li, MD

Phone

0086053284961672

sjogen@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jun Teng, MD

Organizational Affiliation

Qingdao Central Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Mengmei Li

City

Qingdao

State/Province

Shandong

ZIP/Postal Code

266042

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jun Teng, MD

Phone

0086053284961819

owen-145@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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