BELIEVE Study: Nesiritide and Post Myocardial Infarction Left Ventricular Modeling

This study has been terminated.
(recruitment of subjects was halted prematurely. recruiting subjects halted prematurely)
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00252213
First received: November 10, 2005
Last updated: December 9, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention Phase
Myocardial Infarction
Drug: Human BNP
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: B-Type Natriuretic Peptide (Nesiritide) and Post Myocardial Infarction Left Ventricular Remodeling: Pilot Study Assessing Safety

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Estimated Enrollment: 24
Study Start Date: August 2002
Estimated Study Completion Date: January 2006
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 2.5 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252213

Locations
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

ClinicalTrials.gov Identifier: NCT00252213     History of Changes
Other Study ID Numbers: 1218-02, I704.358
Study First Received: November 10, 2005
Last Updated: December 9, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 16, 2014