Trial Outcomes & Findings for Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction (NCT NCT00573144)
NCT ID: NCT00573144
Last Updated: 2014-09-09
Results Overview
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.
COMPLETED
PHASE2
59 participants
baseline, 30 days
2014-09-09
Participant Flow
Subjects were recruited at the Mayo Clinic Cardiac Care Units in Rochester, Minnesota and Jacksonville, Florida.
One subject withdrew consent before randomization.
Participant milestones
| Measure |
Placebo
Infusion of 72 hours of saline solution (packaged to match active comparator).
|
Nesiritide
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
COMPLETED
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Infusion of 72 hours of saline solution (packaged to match active comparator).
|
Nesiritide
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
Baseline Characteristics
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Infusion of 72 hours of saline solution (packaged to match active comparator).
|
Nesiritide
n=25 Participants
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.85 years
STANDARD_DEVIATION 11.12 • n=5 Participants
|
60.4 years
STANDARD_DEVIATION 11.15 • n=7 Participants
|
58.0 years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
25 participants
n=7 Participants
|
53 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, 30 daysChange 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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Infusion of 72 hours of saline solution (packaged to match active comparator).
Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)
|
Nesiritide
n=25 Participants
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Change in Left Ventricular End-Systolic Volume Index
|
-2.1 mL of blood/meter^2 body surface area
Standard Deviation 58
|
-4.6 mL of blood/meter^2 body surface area
Standard Deviation 31
|
SECONDARY outcome
Timeframe: baseline, 30 daysChange in Left Ventricular end-systolic diastolic volume index 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.
Outcome measures
| Measure |
Placebo
n=28 Participants
Infusion of 72 hours of saline solution (packaged to match active comparator).
Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)
|
Nesiritide
n=25 Participants
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Change in Left Ventricular End-Systolic Diastolic Volume Index
|
4.4 mL blood/meter^2 body surface area
Standard Deviation 88
|
9.7 mL blood/meter^2 body surface area
Standard Deviation 51
|
SECONDARY outcome
Timeframe: 30 daysMyocardial infarction or acute myocardial infarction (AMI) is the medical term for an event commonly known as a heart attack. Myocardial (heart muscle) infarction is tissue death (also known as necrosis) caused by a local lack of oxygen, due to an obstruction of the tissue's blood supply. The resulting heart tissue lesion is referred to as an infarct. A larger size or area of infarct indicates a greater amount of heart tissue death. Myocardial infarct size was measured using a cardiac Magnetic Resonance Imaging (MRI) scan at 30 days and is the mass of the infarcted tissue divided by the mass of the left ventricle times 100%.
Outcome measures
| Measure |
Placebo
n=28 Participants
Infusion of 72 hours of saline solution (packaged to match active comparator).
Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)
|
Nesiritide
n=25 Participants
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Myocardial Infarct Size at 30 Days
|
17 percentage of total cardiac tissue mass
Standard Deviation 14
|
12 percentage of total cardiac tissue mass
Standard Deviation 9
|
Adverse Events
Placebo
Nesiritide
Serious adverse events
| Measure |
Placebo
n=28 participants at risk
Infusion of 72 hours of saline solution (packaged to match active comparator).
|
Nesiritide
n=25 participants at risk
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Cardiac disorders
Left ventricle aneurysm or thrombus
|
7.1%
2/28 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Hospital readmission for chest pain
|
7.1%
2/28 • Number of events 2
|
0.00%
0/25
|
|
General disorders
Hospital readmission for other reasons (not chest pain)
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Infusion of 72 hours of saline solution (packaged to match active comparator).
|
Nesiritide
n=25 participants at risk
Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
|
|---|---|---|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Post coronary angiogram related complications
|
14.3%
4/28 • Number of events 4
|
12.0%
3/25 • Number of events 3
|
|
Cardiac disorders
Subsequent coronary angiogram with no intervention
|
7.1%
2/28 • Number of events 2
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Subsequent coronary angiogram with intervention other than LAD
|
10.7%
3/28 • Number of events 3
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Persistent ECG ST changes
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Recurrent chest pain
|
3.6%
1/28 • Number of events 1
|
4.0%
1/25 • Number of events 1
|
|
Cardiac disorders
Vasovagal spell
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
General disorders
MRI dye allergy
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
Respiratory, thoracic and mediastinal disorders
Asthma flare
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Infections and infestations
Fever
|
7.1%
2/28 • Number of events 2
|
0.00%
0/25
|
|
Cardiac disorders
First episode of hypotension (asymptomatic)
|
46.4%
13/28 • Number of events 13
|
52.0%
13/25 • Number of events 13
|
|
Cardiac disorders
First episode of hypotension (symptomatic)
|
0.00%
0/28
|
8.0%
2/25 • Number of events 2
|
|
Cardiac disorders
Second episode of hypotension (asymptomatic)
|
25.0%
7/28 • Number of events 7
|
40.0%
10/25 • Number of events 10
|
|
Cardiac disorders
Second episode of hypotension (symptomatic)
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place