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

September 18, 2021 updated by: Qingdao Central Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mengmei Li, MD
  • Phone Number: 0086053284961672
  • Email: sjogen@163.com

Study Locations

  • China
    • Shandong
      • Qingdao, Shandong, China, 266042
        • Mengmei Li
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sacubitril/Valsartan
Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
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
Other Names:
  • Sacubitril/Valsartan Group
Active Comparator: Valsartan
1 tablet of Valsartan every 24 hours for 6 months
Drug: Valsartan 80mg/Tab
Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.
Other Names:
  • Valsartan Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of MACE events no.1 by phone calls and questionnaires
Time Frame: 6 months
To assess the rate of myocardial infarction in post-infarction patients during the study follow-up.
6 months
Rate of MACE events No.2 by phone calls and questionnaires
Time Frame: 6 months
To assess the rate of stroke in patients post-MI during the follow up period
6 months
Rate of MACE events No.3 phone calls and questionnaires
Time Frame: 6 months
To assess the rate of death from cardiovascular causes during the follow up time
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Left ventricular ejection fraction(LVEF) by echocardiography
Time Frame: 6 months
Evaluate baseline left ventricular ejection fraction (LVEF)in post-infarct patients and 6 months of treatment.
6 months
Rate of post infarction angina by following up in the clinic
Time Frame: 6 months
Evaluate the Effect of Sacubitril/Valsartan versus Valsartan on the development of post-infarction angina.
6 months
The rate of heart failure occurrence by following up in the clinic
Time Frame: 6 months
Assess the occurence of heart failure during the study follow-up.
6 months
Left ventricular end-diastolic volume(LVEDV) by echocardiography
Time Frame: 6 months
Evaluate the baseline LVEDV in post-infarct patients and 6 months of treatment using echocardiography
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qingdao Central Hospital

Investigators

  • Study Director: Jun Teng, MD, Qingdao Central Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

September 13, 2021

First Submitted That Met QC Criteria

September 18, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

September 29, 2021

Last Update Submitted That Met QC Criteria

September 18, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sacu-HPT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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