NCT00252213

Brief Summary

This study is being done to determine the effects (good and bad) of intravenous infusion of a human brain natriuretic peptide (BNP), Natrecor (nesiritide), a hormone produced by the heart in persons who have just suffered a heart attack. The human BNP, Natrecor (nesiritide) has been approved by the United States Food and Drug Administration (FDA) to be given intravenously for the management of acute heart failure. It is unknown if human BNP may have good effects on the pumping function of the heart after a heart attack.

Trial Health

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Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2002

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

November 10, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

December 11, 2009

Status Verified

December 1, 2009

First QC Date

November 10, 2005

Last Update Submit

December 9, 2009

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • Determine the safety of nesiritide at two different dose levels of 0.003 µg/Kg/min and 0.006 µg/Kg/min focusing on the occurrence of hypotension (yes versus no)

  • Dosing finding comparing the efficacy of 0.003 µg/Kg/min and 0.006 µg/Kg/min on the suppression of aldosterone at 6 hours after the start of infusion as compared to baseline, as a marker of the neurohumoral activity of BNP

Secondary Outcomes (1)

  • Compare the safety of the two doses on left ventricular (LV) remodeling by determining the LV volume and function by multiple gate acquistion scan (MUGA)

Interventions

Human BNPDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients with acute ST elevation myocardial infarction of at least \> 2mV ST elevation in two or more anterior precordial leads, with successful revascularization (Thrombolysis in Myocardial Infarction \[TIMI\] grade 3 flow) of the lesion within 24 hours of chest pain as documented by coronary angiogram.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Horng H. Chen, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2005

First Posted

November 11, 2005

Study Start

August 1, 2002

Study Completion

January 1, 2006

Last Updated

December 11, 2009

Record last verified: 2009-12

Locations

US(1)