Clinical trial NCT00573144: Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction
Official title: Nesiritide Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myocardial Infarction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

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.

Primary outcomes:
measure: Change in Left Ventricular End-Systolic Volume Index
timeFrame: baseline, 30 days
Secondary outcomes:
measure: Change in Left Ventricular End-Systolic Diastolic Volume Index
timeFrame: baseline, 30 days
measure: Myocardial Infarct Size at 30 Days
timeFrame: 30 days
Other outcomes:
Locations:
city: Jacksonvilee
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Horng H. Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hubers SA, Schirger JA, Sangaralingham SJ, Chen Y, Burnett JC Jr, Hodge D, Chen HH. B-type natriuretic peptide and cardiac remodelling after myocardial infarction: a randomised trial. Heart. 2021 Mar;107(5):396-402. doi: 10.1136/heartjnl-2020-317182. Epub 2020 Aug 3.