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

Recruiting

• Conditions: Ventricular Remodeling; Myocardial Infarction, Anterior Wall
• Interventions: Drug: Recombinant Human Brain Natriuretic Peptide

• Registration Number: NCT06463808
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-03
• Study First Submitted: 2023-12-13
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-16
• Last Update Submitted: 2024-06-16
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18
• Primary Completion: 2024-12-31
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients who take Recombinant Human Brain Natriuretic Peptide	Recombinant Human Brain Natriuretic Peptide	-

Primary Outcome Measures

Name	Time	Method
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)	from baseline to 6 months	LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)	from baseline to 6 months	LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area
N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level	from baseline to 6 months	NT-proBNP is a protein which is an "ingredient" for making the BNP hormone and a sign of heart failure can be obteined by blood
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)	from baseline to 6 months	LVEF refers to the percentage of stroke output to left ventricular end-diastolic
The level of Cardiac Troponin T(cTnT)	from baseline to 6 months	The level of Cardiac Troponin T(cTnT) at 6 month

Secondary Outcome Measures

Name	Time	Method
Adverse cardiovascular events	from baseline to 6 months

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China