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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Horng Chen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00573144
First received: December 13, 2007
Last updated: November 8, 2012
Last verified: November 2012
  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: Nesiritide versus Placebo
Drug: Nesiritide v. placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Nesiritide Therapy for the Preservation of Left Ventricular Function Post Anterior Myocardial Infarction

Resource links provided by NLM:


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: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Infusion of Nesiritide versus Placebo
Drug: Nesiritide versus Placebo
Infusion of 72 hours of IV nesiritide (Natrecor) at 0.006 mcg/kg/min as compared to placebo
Other Name: Nesiritide (Natrecor, BNP)
Active Comparator: Nesiritide
Infusion of Nesiritide v. placebo
Drug: Nesiritide v. placebo
Infusion of 72 hours of IV nesiritide (Natrecor) at 0.006 mcg/kg/min as compared to placebo
Other Name: Natrecor(BNP), Nesiritide

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 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 CHF
  • Previous history of MI
  • Previous ECG suggesting previous MI
  • Known EF < 30%
  • Atrial fibrillation
  • Previously known significant valvular disease (Grade III, IV), cardiomyopathy and congenital heart disease.
  • Hemoglobin <10mg/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. Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573144

Locations
United States, Florida
Mayo Clinic
Jacksonvilee, Florida, United States, 32224
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Horng H. Chen, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: Horng Chen, Horng Chen, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00573144     History of Changes
Other Study ID Numbers: 06-002180
Study First Received: December 13, 2007
Last Updated: November 8, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Anterior Wall Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014