Ventricular RemodelingNCT06463808
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 of Ventricular Remodeling and Myocardial Infarction, Anterior Wall, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ventricular Remodeling, Myocardial Infarction, Anterior Wall
- What is being tested?
- Recombinant Human Brain Natriuretic Peptide
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2023to 28 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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 ).
Who may be able to join
- The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
- Age 18-75 years old, gender unlimited
- Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
- Successful reflow after interventional therapy ( TIMI = 3 ).
- To understand and sign the informed consent.
Who cannot join
- Patients with a history of coronary artery bypass grafting
- Patients with cardiogenic shock
- Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
- Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
- Patients with suspected aortic dissection
- Patients with severe liver and kidney dysfunction
Show all 11Show fewer
- Allergic or intolerant to rhBNP.
- Patients with chronic renal insufficiency requiring long-term dialysis
- Patients using diuretics during the screening period
- Pregnant / lactating women
- Heart diseases that are not suitable for vasodilators, such as severe valve stenosis, restrictive cardiomyopathy, restrictive pericarditis, etc
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
LianSheng Wang, 85 25 68303830, drlswang@njmu.edu.cn
About this study
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).
- Being tested
- Recombinant Human Brain Natriuretic Peptide
- Keywords
- Myocardial Infarction, Anterior Wall, Recombinant Human Brain Natriuretic Peptide, Ventricular Remodeling, Percutaneous Coronary Intervention
- Medical subject headings
- Ventricular Remodeling, Anterior Wall Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human Brain Natriuretic PeptideDrug
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
| Study group | Role | What they receive |
|---|---|---|
| patients who take Recombinant Human Brain Natriuretic Peptide | Not described Receives: Drug: Recombinant Human Brain Natriuretic Peptide | |
| patients who do not take Recombinant Human Brain Natriuretic Peptide | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrasonic cardiogram：left ventricle ejection fraction (LVEF)
LVEF refers to the percentage of stroke output to left ventricular end-diastolic
Measured: from baseline to 6 months
ultrasonic cardiogram：left ventricular end-diastolic volume index (LVEDVI)
LVEDVI（ml/m2）=left ventricular end-diastolic volume（ml）/body surface area
Measured: from baseline to 6 months
ultrasonic cardiogram：left ventricular end-systolic volume index (LVESVI)
LVESVI（ml/m2）=left ventricular end-systolic volume（ml）/body surface area
Measured: from baseline to 6 months
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
Measured: from baseline to 6 months
The level of Cardiac Troponin T(cTnT)
The level of Cardiac Troponin T(cTnT) at 6 month
Measured: from baseline to 6 months
Secondary outcomes (1)
Adverse cardiovascular events
Measured: from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start3 May 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular RemodelingStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463808
- Sponsor's protocol ID
- REBUILD-AAMI
- Status last verified
- Jun 2024
- First submitted
- 13 Dec 2023
- Last updated
- 18 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06463808
- Acronym / sponsor ID
- REBUILD-AAMI
- Keywords
- Myocardial Infarction, Anterior Wall, Recombinant Human Brain Natriuretic Peptide, Ventricular Remodeling, Percutaneous Coronary Intervention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients who take Recombinant Human Brain Natriuretic Peptide | – | Drug: Recombinant Human Brain Natriuretic Peptide |
| patients who do not take Recombinant Human Brain Natriuretic Peptide | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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 ).
Key inclusion criteria (5 listed)
- The first acute anterior myocardial infarction ( AMI ) within 12 hours ( or more than 12 hours but the ischemic symptoms continue ).
- Age 18-75 years old, gender unlimited
- Patients with acute anterior myocardial infarction undergoing emergency PCI within the effective time window
- Successful reflow after interventional therapy ( TIMI = 3 ).
- To understand and sign the informed consent.
Key exclusion criteria (11 listed)
- Patients with a history of coronary artery bypass grafting
- Patients with cardiogenic shock
- Patients with systolic blood pressure ( SBP ) ≤ 90 mmHg after treatment with vasopressors
- Patients with mechanical complications ( ventricular septal perforation, mitral chordae rupture )
- Patients with suspected aortic dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human Brain Natriuretic Peptidewe 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 | Drug | patients who take Recombinant Human Brain Natriuretic Peptide |
Primary outcome
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
1 secondary outcome
Adverse cardiovascular events
Time frame: from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Remodeling and Myocardial Infarction, Anterior Wall, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LianSheng Wang (1339078711, drlswang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ultrasonic cardiogram：left ventricle ejection fraction (LVEF) (time frame: from baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.