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Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction (BelieveII)
This study is currently recruiting participants.
Verified by Mayo Clinic, December 2007
Sponsored by: Mayo Clinic
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00573144
  Purpose

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.


Condition Intervention Phase
Acute Myocardial Infarction
Drug: Nasiritide vs. Placebo
Phase II

MedlinePlus related topics: Heart Attack
Drug Information available for: Nesiritide
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: Neseritide Therapy for the Preservation of Left Ventricular Function Post Anteriot Myocardial Infarction

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • LV end systolic and diastolic dimensions determined by MUGA at 30 days as compared to baseline and between placebo group. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • EF and diastolic function determined by MUGA/ECHO at 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • 30 day combined total mortality and hospitalization for CHF [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Circulating ANP, BNP, ET and Aldosterone [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Infarct size and LV mass as determined by cardiac MRI [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2006
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Placebo Comparator Drug: Nasiritide vs. Placebo
Infusion of 72 hours of IV naseritide (Natrecor) at 0.006 mcg/kg/min as compared to placebo

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, 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 CCU 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Patients with acute ST elevation myocardial infarction of at least >1.5 mV ST elevation in two or more anterior leads, with successful revascularization (TIMI grade 3 flow) of the lesion within 24 hours of symptoms as documented by coronary angiogram.

Exclusion criteria:

  • Cardiogenic shock or hypotension, Systolic BP< 90 mmHg or overt CHF
  • Previous history of MI
  • Previous ECG suggesting previous MI
  • Previously known decreased EF
  • Atrial fibrillation
  • Previously known significant valvular disease (Grade III, IV), HOCM and congenital heart disease.
  • Hemoglobin <10mg/dl.
  • Pregnant women/nursing mothers
  • Participants still menstruating and have not been surgiclly sterilized must have a negative pregnancy test prior to particiapting in this study.
  • Unable to undergo cardiac MRI. Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00573144

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lynn E. Polk, BSN     507-255-2527     polk.lynn@mayo.edu    
Principal Investigator: Horng H. Chen, M.D.            
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Horng H. Chen, M.D. Mayo Clinic
  More Information

Responsible Party: Mayo Clinic ( Horng H. Chen, M.D. )
Study ID Numbers: 06-002180
Study First Received: December 13, 2007
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00573144  
Health Authority: United States: Food and Drug Administration;   United States: Institutional Review Board

Study placed in the following topic categories:
Natriuretic Peptide, Brain
Necrosis
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009