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
Effect of Recombinant Human Brain Natriuretic Peptide on Ventricular Remodeling and Cardiac Function in Patients With Acute Anterior Myocardial Infraction Undergoing Percutaneous Coronary Intervention
Status
Unknown
Phase
Not applicable
Enrollment
100
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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).
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jun 18, 2024
Study start
May 3, 2023
Primary completion
Dec 31, 2024
Study completion
Feb 28, 2025
Results posted
Not reported
Registry updated
Jun 18, 2024
Outcomes
What the study measures.
Primary outcomes
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
Time frame · from baseline to 6 months
LVEF refers to the percentage of stroke output to left ventricular end-diastolic
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
Time frame · from baseline to 6 months
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
Time frame · from baseline to 6 months
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area
N terminal pro-B-type natriuretic peptide（NT-proBNP ）decline level
Time frame · 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
The level of Cardiac Troponin T(cTnT)
Time frame · from baseline to 6 months
The level of Cardiac Troponin T(cTnT) at 6 month
Secondary outcomes
Adverse cardiovascular events
Time frame · from baseline to 6 months
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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