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

June 16, 2024 updated by: The First Affiliated Hospital with Nanjing Medical University
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • The First Affiliated Hospital of Nanjing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

People who are about 18 to 75 years old get the first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ) and undergo emergency PCI within the effective time window,after which the blood reflows ( TIMI = 3 ).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients who take Recombinant Human Brain Natriuretic Peptide
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
patients who do not take Recombinant Human Brain Natriuretic Peptide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
from baseline to 6 months
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
from baseline to 6 months
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
from baseline to 6 months
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
from baseline to 6 months
The level of Cardiac Troponin T(cTnT)
Time Frame: from baseline to 6 months
The level of Cardiac Troponin T(cTnT) at 6 month
from baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse cardiovascular events
Time Frame: from baseline to 6 months
from baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 3, 2023

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

February 28, 2025

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

June 16, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 16, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REBUILD-AAMI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ventricular Remodeling

Clinical Trials on Recombinant Human Brain Natriuretic Peptide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kyrgyzstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe