- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573144
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction (Believe II)
September 2, 2014 updated by: Horng Chen, Mayo Clinic
Nesiritide Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction
The purpose of this study is to determine the efficacy of intravenous human beta natriuretic peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial infarction left ventricular remodeling.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Post acute myocardial infarction (AMI) left ventricular (LV) remodeling begins within hours of the acute event with permanent consequences.
Previous studies have demonstrated that LV remodeling is one of the major determinants of long-term survival post AMI.
Recent studies have reported that the cardiac natriuretic peptides, atrial natriuretic peptide (ANP) and BNP have direct anti-fibrotic and anti-proliferative effects on the myocardium.
More importantly, it has been reported that in the acute phase of AMI, the secretion of the cardiac natriuretic peptides may be insufficient relative to the chronic phase.
Therefore, augmentation of the cardiac natriuretic peptide system, such as by exogenous administration of exogenous peptide may prevent post AMI LV remodeling because of the cardioprotective effects.
The objective of this study is to to determine the efficacy of IV human BNP (Nesiritide) as compared to placebo to prevent adverse post AMI LV remodeling.
This is a randomized double blinded placebo controlled study to determine efficacy of 72 hours of IV BNP at 0.006µg/Kg/min as compared to placebo in patients with anterior ST-elevation myocardial infarction and successful revascularization.
The study population will include 60 patients admitted to the Cardiac Care Unit with a first anterior AMI and successful reperfusion therapy (TIMI grade 3 flow) within 24 hours of onset of chest pain documented by coronary angiography.
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Jacksonvilee, Florida, United States, 32224
- Mayo Clinic
-
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion criteria:
- Patients with acute ST elevation myocardial infarction with > or = 2 mm ST elevation in one or any combination of anterior leads, with successful revascularization (TIMI grade 3 flow) of the lesion within 24 hours of symptoms and consented within 24 hours of procedure.
Exclusion criteria:
- Cardiogenic shock or hypotension, Systolic BP< 90 mmHg or overt Congestive Heart Failure (CHF)
- Previous history of MI (Myocardial Infarction)
- Previous ECG suggesting previous MI
- Known Ejection Fraction (EF) < 30%
- Atrial fibrillation
- Previously known significant valvular disease (Grade III, IV), cardiomyopathy and congenital heart disease.
- Hemoglobin <10 mg/dL
- Pregnant women/nursing mothers
- Participants still menstruating and have not been surgically sterilized must have a negative pregnancy test prior to participating in this study.
- Unable to undergo cardiac MRI (Magnetic Resonance Imaging).
- Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Infusion of 72 hours of saline solution (packaged to match active comparator).
|
Infusion of 72 hours of saline solution (packaged to match active comparator)
|
Active Comparator: Nesiritide
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Left Ventricular End-Systolic Volume Index
Time Frame: baseline, 30 days
|
Change in Left Ventricular end-systolic volume index as determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days.
The MUGA scan is a noninvasive tool for assessing the function of the heart.
The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers).
End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.
|
baseline, 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Left Ventricular End-Systolic Diastolic Volume Index
Time Frame: baseline, 30 days
|
Change in Left Ventricular end-systolic diastolic volume index determined by Multiple Gated Acquisition (MUGA) scan from baseline to 30 days.
The MUGA scan is a noninvasive tool for assessing the function of the heart.
The MUGA scan produces a moving image of the beating heart, and from this image several important features can be determined about the health of the cardiac ventricles (the heart's major pumping chambers).
End-systolic volume (ESV) is the volume of blood in a ventricle at the end of contraction, or systole, and the beginning of filling, or diastole.
ESV is the lowest volume of blood in the ventricle at any point in the cardiac cycle and can be used clinically as a measurement of the adequacy of cardiac emptying, related to systolic function.
|
baseline, 30 days
|
Myocardial Infarct Size at 30 Days
Time Frame: 30 days
|
Myocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack.
Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply.
The resulting heart tissue lesion is referred to as an infarct.
A larger size or area of infarct indicates a greater amount of heart tissue death.
Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%.
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30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
September 1, 2006
Primary Completion (Actual)
November 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
December 13, 2007
First Submitted That Met QC Criteria
December 13, 2007
First Posted (Estimate)
December 14, 2007
Study Record Updates
Last Update Posted (Estimate)
September 9, 2014
Last Update Submitted That Met QC Criteria
September 2, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-002180
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.
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