Phase 2
N=58
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction
Acute Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00573144 ↗Enrolled (actual)
58
Serious AEs
11.3%
Results posted
Sep 2014
Primary outcome: Primary: Change in Left Ventricular End-Systolic Volume Index — -2.1; -4.6 mL of blood/meter^2 body surface area — p=0.97
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Nesiritide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular End-Systolic Volume Index |
-2.1; -4.6 | 0.97 |
| SECONDARY Change in Left Ventricular End-Systolic Diastolic Volume Index |
4.4; 9.7 | 0.35 |
| SECONDARY Myocardial Infarct Size at 30 Days |
17; 12 | 0.26 |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00573144). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.