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

Ventricular Remodeling Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06463808
• Other study ID #: REBUILD-AAMI
• Status: Recruiting
• Start date: May 3, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: June 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: LianSheng Wang
• Phone: 1339078711
• Email: drlswang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 28, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Wall Myocardial Infarction
• Infarction
• Myocardial Infarction
• Myocardial Infarction, Anterior Wall
• Ventricular Remodeling

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ultrasonic cardiogram:left ventricle ejection fraction (LVEF)	LVEF refers to the percentage of stroke output to left ventricular end-diastolic	from baseline to 6 months
Primary	ultrasonic cardiogram:left ventricular end-diastolic volume index (LVEDVI)	LVEDVI(ml/m2)=left ventricular end-diastolic volume(ml)/body surface area	from baseline to 6 months
Primary	ultrasonic cardiogram:left ventricular end-systolic volume index (LVESVI)	LVESVI(ml/m2)=left ventricular end-systolic volume(ml)/body surface area	from baseline to 6 months
Primary	N terminal pro-B-type natriuretic peptide(NT-proBNP )decline level	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	from baseline to 6 months
Primary	The level of Cardiac Troponin T(cTnT)	The level of Cardiac Troponin T(cTnT) at 6 month	from baseline to 6 months
Secondary	Adverse cardiovascular events		from baseline to 6 months