Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention

NCT ID: NCT06463808

Last Updated: 2024-06-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-05-03
• Study Completion Date: 2025-02-28

Brief Summary

This study is designed to evaluate the efficacy and safety of Recombinant Human Brain Natriuretic Peptide (rhBNP) in improving ventricular remodeling and cardiac function after acute anterior myocardial infarction undergoing percutaneous coronary intervention. 100 patients with acute anterior myocardial infarction after primary Percutaneous Coronary Intervention (pPCI) are randomly assigned 1:1 to rhBNP group(n=50) and control group(n=50) with follow-up of 24 weeks. Both groups are treated with standard therapy of AAMI, with the rhBNP group intravenous dripping rhBNP after pPCI for 3 days and the control group treated with placebo at the same time. The primary endpoint is the change in N terminal pro-B-type natriuretic peptide（NT-proBNP ）and cardiac troponin T(cTnT) level.The secondary endpoint is the change in 24-week echocardiographic including left ventricle ejection fraction (LVEF) , left ventricular end-diastolic volume index (LVEDVI) and left ventricular end-systolic volume index (LVESVI), arrhythmia and cardiovascular events (death, cardiac arrest or cardiopulmonary resuscitation, hospitalization due to heart failure or angina pectoris).

Conditions

Ventricular Remodeling; Myocardial Infarction, Anterior Wall

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients who take Recombinant Human Brain Natriuretic Peptide

Recombinant Human Brain Natriuretic Peptide

Intervention Type: DRUG

we divide our subjects into two groups;one is required to take recombinant human brain natriuretic peptide,the other is not required to take recombinant human brain natriuretic peptide

patients who do not take Recombinant Human Brain Natriuretic Peptide

No interventions assigned to this group

Interventions

Recombinant Human Brain Natriuretic Peptide

we divide our subjects into two groups;one is required to take recombinant human brain natriuretic peptide,the other is not required to take recombinant human brain natriuretic peptide

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).

2. Age 18-75 years old, gender unlimited

3. Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window

4. Successful reflow after interventional therapy ( TIMI = 3 ).

5. To understand and sign the informed consent.

Exclusion Criteria

1. Patients with a history of coronary artery bypass grafting

2. Patients with cardiogenic shock

3. Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors

4. Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )

5. Patients with suspected aortic dissection

6. Patients with severe liver and kidney dysfunction

7. Allergic or intolerant to rhBNP.

8. Patients with chronic renal insufficiency requiring long-term dialysis

9. Patients using diuretics during the screening period

10. Pregnant / lactating women

11. Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

LianSheng Wang

Role: CONTACT

drlswang@njmu.edu.cn

1339078711

Yang Yang

Role: CONTACT

273389782@qq.com

15895876832

Facility Contacts

LianSheng Wang

Role: primary

drlswang@njmu.edu.cn

85 25 68303830

Other Identifiers

REBUILD-AAMI

Identifier Type: -

Identifier Source: org_study_id