Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252213
Status:
TERMINATED
Last Update Posted:
2009-12-11
First Post:
2005-11-10
Brief Title:
BELIEVE Study Nesiritide and Post Myocardial Infarction Left Ventricular Modeling
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
B-Type Natriuretic Peptide Nesiritide and Post Myocardial Infarction Left Ventricular Remodeling Pilot Study Assessing Safety
Status:
TERMINATED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
recruitment of subjects was halted prematurely recruiting subjects halted prematurely
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
During the 72 hours of intravenous IV nesiritide infusion if the systolic blood pressure decreases to less than 90 mmHg for 5 minutes the coronary care unit CCU sx will be notified and if the systolic blood pressure has not increased to or equal to 90 mmHg within 45 minutes the nesiritide infusion will be stopped All patients will receive other medical therapy as determined appropriate by the physician except for angiotensin converting enzyme inhibitor ACEI which will be started 24 hours after IV nesiritide Lisinopril will be started 24 hours after the start of IV nesiritide at an initial dose of 25 mg and to be titrated up by the participants physician according to their clinical status The window for the lisinopril doses would be - 1 hour
Patients with any signs or symptoms of post revascularization ischemia will be discontinued from the study
Blood for the measurement of renin angiotensin II Ang II aldosterone Aldo endothelin ET-1 norepinephrine atrial natriuretic peptide ANP brain natriuretic peptide BNP cGMP C reactive protein tumor necrosis factor TNF-alpha matrix metalloproteinase MMP-2 and tissue inhibitor of metalloproteinase TIMP-2 will be drawn before the initiation of IV nesiritide six hours into the infusion before the initiation of ACEI and just before completion of the 72 hour infusion The window for the blood draw for the six hour time point would be - 1 hour and the 72 hour time point would be -1 hour or just prior to discharge but not less than 66 hours
MUGA will be performed within 24 hours after the initiation of the IV nesiritide to assess systolic and diastolic volumes and LV ejection fraction EF
Follow up at 4 weeks
All patients whether they complete the entire 72 hours of the nesiritide infusion or not will return 1 month later for a repeat MUGA and blood draw for the neurohumoral profiling and pregnancy test if required by nuclear cardiology The visit window for the one month return would be 30 to 40 days
Patients with any signs or symptoms of post revascularization ischemia will be discontinued from the study
Blood for the measurement of renin angiotensin II Ang II aldosterone Aldo endothelin ET-1 norepinephrine atrial natriuretic peptide ANP brain natriuretic peptide BNP cGMP C reactive protein tumor necrosis factor TNF-alpha matrix metalloproteinase MMP-2 and tissue inhibitor of metalloproteinase TIMP-2 will be drawn before the initiation of IV nesiritide six hours into the infusion before the initiation of ACEI and just before completion of the 72 hour infusion The window for the blood draw for the six hour time point would be - 1 hour and the 72 hour time point would be -1 hour or just prior to discharge but not less than 66 hours
MUGA will be performed within 24 hours after the initiation of the IV nesiritide to assess systolic and diastolic volumes and LV ejection fraction EF
Follow up at 4 weeks
All patients whether they complete the entire 72 hours of the nesiritide infusion or not will return 1 month later for a repeat MUGA and blood draw for the neurohumoral profiling and pregnancy test if required by nuclear cardiology The visit window for the one month return would be 30 to 40 days
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I704358 | None | None | None |