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RecruitingNCT06463808Updated Jun 18, 2024

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

An observational study in Ventricular Remodeling and Myocardial Infarction, Anterior Wall, sponsored by The First Affiliated Hospital with Nanjing Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-06-18.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Ventricular Remodeling
  • Myocardial Infarction, Anterior Wall

Keywords

  • Myocardial Infarction, Anterior Wall
  • Recombinant Human Brain Natriuretic Peptide
  • Ventricular Remodeling
  • Percutaneous Coronary Intervention
03

In context

Ventricular Remodeling

105 studies on the registry are indexed under Ventricular Remodeling; 24 are open to participants now.

This study's planned enrollment of 100 is below the median of 180 across 32 observational studies indexed under Ventricular Remodeling.

Browse Ventricular Remodeling studies →

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 568 studies on the registry; 317 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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 ).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • patients who take Recombinant Human Brain Natriuretic Peptide

    Drug: Recombinant Human Brain Natriuretic Peptide

  • patients who do not take Recombinant Human Brain Natriuretic Peptide

Interventions

  • DrugRecombinant 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

06

What researchers measure

Primary outcomes

  1. ultrasonic cardiogram:left ventricle ejection fraction (LVEF)

    LVEF refers to the percentage of stroke output to left ventricular end-diastolic

    Time frame: from baseline to 6 months

  2. ultrasonic cardiogram:left ventricular end-diastolic volume index (LVEDVI)

    LVEDVI(ml/m2)=left ventricular end-diastolic volume(ml)/body surface area

    Time frame: from baseline to 6 months

  3. ultrasonic cardiogram:left ventricular end-systolic volume index (LVESVI)

    LVESVI(ml/m2)=left ventricular end-systolic volume(ml)/body surface area

    Time frame: from baseline to 6 months

  4. 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

    Time frame: from baseline to 6 months

  5. The level of Cardiac Troponin T(cTnT)

    The level of Cardiac Troponin T(cTnT) at 6 month

    Time frame: from baseline to 6 months

Secondary outcomes

  1. Adverse cardiovascular events

    Time frame: from baseline to 6 months

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06463808
Responsible party
Sponsor
First posted
Jun 18, 2024
Start date
May 3, 2023
Primary completion
Dec 31, 2024 (estimated)
Completion
Feb 28, 2025 (estimated)
Last update
Jun 18, 2024

Study contacts

LianSheng Wang
Contact
drlswang@njmu.edu.cn
1339078711
Yang Yang
Contact
273389782@qq.com
15895876832

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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