Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05060588
Other study ID # Sacu-HPT
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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 investigatorĀ“s clinical judgment. 8. Currently on treatment with Sacubitril/Valsartan or an ACEI/ARB.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Terminated NCT04591808 - Efficacy and Safety of Atorvastatin + Perindopril Fixed-Dose Combination S05167 in Adult Patients With Arterial Hypertension and Dyslipidemia Phase 3
Recruiting NCT04515303 - Digital Intervention Participation in DASH
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Completed NCT03093532 - A Hypertension Emergency Department Intervention Aimed at Decreasing Disparities N/A
Completed NCT04507867 - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III N/A
Completed NCT05529147 - The Effects of Medication Induced Blood Pressure Reduction on Cerebral Hemodynamics in Hypertensive Frail Elderly
Recruiting NCT05976230 - Special Drug Use Surveillance of Entresto Tablets (Hypertension)
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Completed NCT06008015 - A Study to Evaluate the Pharmacokinetics and the Safety After Administration of "BR1015" and Co-administration of "BR1015-1" and "BR1015-2" Under Fed Conditions in Healthy Volunteers Phase 1
Completed NCT05387174 - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period N/A
Completed NCT04082585 - Total Health Improvement Program Research Project
Recruiting NCT05121337 - Groceries for Black Residents of Boston to Stop Hypertension Among Adults Without Treated Hypertension N/A
Withdrawn NCT04922424 - Mechanisms and Interventions to Address Cardiovascular Risk of Gender-affirming Hormone Therapy in Trans Men Phase 1
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT05087290 - LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR)
Not yet recruiting NCT05038774 - Educational Intervention for Hypertension Management N/A
Completed NCT05621694 - Exploring Oxytocin Response to Meditative Movement N/A
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Recruiting NCT05575453 - OPTIMA-BP: Empowering PaTients in MAnaging Blood Pressure N/A