NCT00573144

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2006

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2007

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 9, 2014

Completed
Last Updated

September 9, 2014

Status Verified

September 1, 2014

Enrollment Period

6.2 years

First QC Date

December 13, 2007

Results QC Date

September 2, 2014

Last Update Submit

September 2, 2014

Conditions

Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

  • Change in Left Ventricular End-Systolic Volume Index

    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.

    baseline, 30 days

Secondary Outcomes (2)

  • Change in Left Ventricular End-Systolic Diastolic Volume Index

    baseline, 30 days

  • Myocardial Infarct Size at 30 Days

    30 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Infusion of 72 hours of saline solution (packaged to match active comparator).

Drug: Placebo

Nesiritide

ACTIVE COMPARATOR

Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.

Drug: Nesiritide

Interventions

NesiritideDRUG

Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.

Also known as: Natrecor, BNP
Nesiritide
PlaceboDRUG

Infusion of 72 hours of saline solution (packaged to match active comparator)

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Jacksonvilee, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • 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.

    PMID: 32747497DERIVED

MeSH Terms

Interventions

Natriuretic Peptide, Brain

Intervention Hierarchy (Ancestors)

Natriuretic PeptidesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteins

Results Point of Contact

Title
Dr. Horng H. Chen
Organization
Mayo Clinic
chen.horng@mayo.edu
507-284-1644

Study Officials

  • Horng H. Chen, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Horng Chen, M.D.

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 14, 2007

Study Start

September 1, 2006

Primary Completion

November 1, 2012

Study Completion

April 1, 2013

Last Updated

September 9, 2014

Results First Posted

September 9, 2014

Record last verified: 2014-09

Locations

US(2)