Trial Outcomes & Findings for Statin Therapy for Ischemic and Nonischemic Cardiomyopathy (NCT NCT00701220)
NCT ID: NCT00701220
Last Updated: 2023-07-18
Results Overview
Change in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence.
COMPLETED
PHASE4
9 participants
Baseline - 6 months
2023-07-18
Participant Flow
Patients were eligible for enrollment if they had dilated cardiomyopathy w/ an established ejection fraction \< 35% on a nonischemic or ischemic basis. All pts had clinical indication for treatment w/ a statin Rx \& did not receive a statin medication prior to enrollment in the study.
Patients with cardiomyopathy on the basis of valvular heart disease or who had a myocardial infarction within six months prior to study enrollment were excluded from the study.
Participant milestones
| Measure |
Ischemic Cardiomyopathy
Patients with Ischemic Cardiomyopathy receiving Lipitor.
|
NonIschemic Cardiomyopathy
NonIschemic Cardiomyopathy receiving Lipitor treatment
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
6
|
|
Overall Study
COMPLETED
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
Ischemic Cardiomyopathy
Patients with Ischemic Cardiomyopathy receiving Lipitor.
|
NonIschemic Cardiomyopathy
NonIschemic Cardiomyopathy receiving Lipitor treatment
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
|
Overall Study
Protocol Violation
|
2
|
0
|
Baseline Characteristics
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
Baseline characteristics by cohort
| Measure |
Ischemic Cardiomyopathy
n=1 Participants
Patients with Ischemic Cardiomyopathy receiving Lipitor.
|
NonIschemic Cardiomyopathy
n=4 Participants
NonIschemic Cardiomyopathy receiving Lipitor treatment
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
51.33 years
STANDARD_DEVIATION 15.29 • n=93 Participants
|
53.66 years
STANDARD_DEVIATION 9.71 • n=4 Participants
|
52.11 years
STANDARD_DEVIATION 17.37 • n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=93 Participants
|
4 participants
n=4 Participants
|
5 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline - 6 monthsChange in Endothelial Progenitor Cells (EPC) was assessed by extracting white blood cells from blood samples and labeling the white blood cells using the ALDEFLOUR system. Facscan analysis was then performed first isolating lymphocytic and monocytic cell lines, which contain the EPC populations, using forward versus side scatter plots. These cells were then scanned for fluorescence in the ALDEFLUOR frequency range allowing enumeration of progenitor cell lines. The measures of fluorescent cells was compared to numbers of unstained cells having the same back scatter range to correct for any background fluorescence.
Outcome measures
| Measure |
Ischemic Cardiomyopathy
n=1 Participants
Patients with Ischemic Cardiomyopathy receiving Lipitor (atorvastatin calcium).
|
NonIschemic Cardiomyopathy
n=4 Participants
NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin Calcium) treatment
|
|---|---|---|
|
Change in Endothelial Progenitor Cells
|
-10.01 Percentage of EPCs
Standard Deviation 0
|
5.19 Percentage of EPCs
Standard Deviation 0.517
|
PRIMARY outcome
Timeframe: Baseline - 6 monthsThe primary outcome measure is the percentage of cells of total analyzed that are positive for the Aldofluor assay. This commercially available assay tests cells for the enzyme aldehyde dehydrogenase that is expressed in stem cells and other early life cycle undifferentiated cells. It thus provides a measure of circulating primordial cells or cells that may serve as progenitors of destination mature cells. The percentages are designed from Facscan analysis of prepared blood cells and are quantified by quadrants defined by specific fluorescent bands and cell size distribution. The quantification of cells thus defined in the four quadrants is automatically determined by software resident in the facscan analysis system.
Outcome measures
| Measure |
Ischemic Cardiomyopathy
n=1 Participants
Patients with Ischemic Cardiomyopathy receiving Lipitor (atorvastatin calcium).
|
NonIschemic Cardiomyopathy
n=4 Participants
NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin Calcium) treatment
|
|---|---|---|
|
Percentage Aldofluor Positive Cells
|
6.37 Percentage Aldefluor positive cells
Standard Deviation 0
|
5.7 Percentage Aldefluor positive cells
Standard Deviation 0.5
|
Adverse Events
Ischemic Cardiomyopathy
NonIschemic Cardiomyopathy
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place