Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction (Believe II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00573144
First received: December 13, 2007
Last updated: September 2, 2014
Last verified: September 2014

December 13, 2007
September 2, 2014
September 2006
November 2012   (final data collection date for primary outcome measure)
Change in Left Ventricular End-Systolic Volume Index [ Time Frame: baseline, 30 days ] [ Designated as safety issue: No ]
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.
LV end systolic and diastolic dimensions determined by MUGA at 30 days as compared to baseline and between placebo group.
Complete list of historical versions of study NCT00573144 on ClinicalTrials.gov Archive Site
  • Change in Left Ventricular End-Systolic Diastolic Volume Index [ Time Frame: baseline, 30 days ] [ Designated as safety issue: No ]
    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.
  • Myocardial Infarct Size at 30 Days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    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%.
  • EF and diastolic function determined by MUGA/ECHO at 30 days
  • 30 day combined total mortality and hospitalization for CHF
  • Circulating ANP, BNP, ET and Aldosterone
  • Infarct size and LV mass as determined by cardiac MRI
Not Provided
Not Provided
 
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Acute Myocardial Infarction
  • Drug: Nesiritide
    Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
    Other Names:
    • Natrecor
    • BNP
  • Drug: Placebo
    Infusion of 72 hours of saline solution (packaged to match active comparator)
  • Placebo Comparator: Placebo
    Infusion of 72 hours of saline solution (packaged to match active comparator).
    Intervention: Drug: Placebo
  • Active Comparator: Nesiritide
    Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
    Intervention: Drug: Nesiritide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
April 2013
November 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00573144
06-002180
No
Horng Chen, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Horng H. Chen, M.D. Mayo Clinic
Mayo Clinic
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP