Cardiovascular DiseasePhase 4NCT00701220
Statin Therapy for Ischemic and Nonischemic Cardiomyopathy
A Phase 4 study testing Atorvastatin Calcium in people with Cardiovascular Disease and Cardiomyopathy, run by Philip Binkley at 1 site in United States.
Trial summary
The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cardiovascular Disease, Cardiomyopathy, Heart Disease
- What is being tested?
- Atorvastatin Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Dec 2010
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ischemic Cardiomyopathy (as defined above) with ejection fraction < 35%
- Non-ischemic Cardiomyopathy with ejection fraction < 35%
- NCEP ATPIII indication for therapy with a statin drug
- No statin therapy within previous 6 months of study enrollment
- Prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required
Who cannot join
- Pregnant or lactating
- Myocardial infarction within 6 months preceding study enrollment
- Primary valvular heart disease
- Surgical or catheter based revascularization within the preceding 6 months
- Documented viral or inflammatory myocarditis or cardiomyopathy
- Peripartum cardiomyopathy
Show all 11Show fewer
- Infiltrative cardiomyopathies
- Chemotherapy associated cardiomyopathy
- Without indication for statin therapy
- Contraindication to statin therapy including hepatic dysfunction, history of rhabdomyolysis or prior intolerance of statin therapy
- Contraindication to magnetic resonance imaging
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy
The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by MRI scans.
Read the detailed description
This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional.
You are being asked to provide a blood sample that will be used to determine the usual numbers of EPC's circulating in the blood of healthy people who have no risk factors for heart disease. Your results will be compared with those of patients who have heart failure.
Flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry. Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood vessel formation. EPC's will be separated by flow cytometry and counted. You will not be given the results of your flow cytometry study.
- Conditions
- Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia
- Being tested
- Atorvastatin Calcium
- Keywords
- Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia
- Medical subject headings
- Cardiovascular Diseases, Cardiomyopathies, Heart Diseases, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atorvastatin CalciumDrug
Also called Lipitor
Atorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Cardiomyopathy | Active comparator | Patients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium). Receives: Drug: Atorvastatin Calcium |
| Non Ischemic Cardiomyopathy | Active comparator | NonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment Receives: Drug: Atorvastatin Calcium |
| Healthy Subjects | No intervention | Healthy subjects with no history of high cholesterol, heart disease, or heart attacks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Endothelial Progenitor Cells
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.
Measured: Baseline - 6 months
Percentage Aldofluor Positive Cells
The 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.
Measured: Baseline - 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startApr 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Binkley
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor-investigator, Philip Binkley, Ohio State University
- Investigators
- Philip Binkley, MD, MPH, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701220
- Sponsor's protocol ID
- 2005H0118
- Status last verified
- Jun 2023
- First submitted
- 26 Dec 2007
- Last updated
- 18 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: available through request to the principal investigator; has been presented as an abstract but not a published paper
Publications
Abstract 10678: Increase in the Number of Circulating Primordial Cells is Associated With Improved Left Ventricular Function in Dilated Cardiomyopathy Nkechinyere N Ijioma, Philip F Binkley, and Amanda Lesinski Originally published27 Mar 2018Circulation. 2013;128:A10678
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Statin Induced Augmentation of Circulating Endothelial Progenitor Cells and Myocardial Viability in Patients With Ischemic and Nonischemic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT00701220
- Acronym / sponsor ID
- 2005H0118
- Conditions
- Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia
- Keywords
- Cardiovascular Disease, Cardiomyopathy, Heart Disease, Myocardial Disease, Myocardial Ischemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Philip BinkleyUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Apr 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 19 Jun 2008 (estimated)
- Results
- Posted 18 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see if taking a cholesterol lowering drug Lipitor (Atorvastatin Calcium)will increase the number of endothelial progenitor cells (EPC's) circulating in the blood of heart failure patients taking this cholesterol-lowering drug, and if this will also show an improvement in the damaged areas of the patient's hearts as documented by MRI scans.
Detailed description
This study involves the testing of blood for cholesterol levels and flow cytometry tests to count the number of EPC's in your blood. These tests are routinely performed to gain knowledge about a person's health. If any incidental findings are identified as a result of your participation in this research study, you will be notified and referred to your doctor or appropriate health care professional.
You are being asked to provide a blood sample that will be used to determine the usual numbers of EPC's circulating in the blood of healthy people who have no risk factors for heart disease. Your results will be compared with those of patients who have heart failure.
Flow cytometry is a special laboratory test that can count, separate, and detect characteristics of cells in blood. Your blood sample will be analyzed using flow cytometry. Endothelial progenitor cells (EPC's) are immature cells that are necessary for new blood vessel formation. EPC's will be separated by flow cytometry and counted. You will not be given the results of your flow cytometry study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic Cardiomyopathy | Active comparator | Drug: Atorvastatin CalciumPatients with Ischemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium). |
| Non Ischemic Cardiomyopathy | Active comparator | Drug: Atorvastatin CalciumNonIschemic Cardiomyopathy receiving Lipitor (Atorvastatin calcium) treatment |
| Healthy Subjects | No intervention | –Healthy subjects with no history of high cholesterol, heart disease, or heart attacks |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ischemic Cardiomyopathy (as defined above) with ejection fraction < 35%
- Non-ischemic Cardiomyopathy with ejection fraction < 35%
- NCEP ATPIII indication for therapy with a statin drug
- No statin therapy within previous 6 months of study enrollment
- Prescribed stable doses of standard heart failure therapies including beta blocking agents, angiotensin converting enzyme inhibitors or angiotensin receptor blockers, and diuretic agents as required
Key exclusion criteria (11 listed)
- Pregnant or lactating
- Myocardial infarction within 6 months preceding study enrollment
- Primary valvular heart disease
- Surgical or catheter based revascularization within the preceding 6 months
- Documented viral or inflammatory myocarditis or cardiomyopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin CalciumAlso: LipitorAtorvastatin Calcium starting at a 10 mg dose and may be increased up to 40 mg dose until cholesterol is lowered to an acceptable range. Blood will drawn every 2 weeks for the first 12 weeks to check the cholesterol level and adjust medication dosage. Cardiac MRI will be performed at the beginning and at the end of the 6 month study to measure the physical changes of the heart. | Drug | Ischemic Cardiomyopathy, Non Ischemic Cardiomyopathy |
Primary outcome
Change in Endothelial Progenitor Cells
Time frame: Baseline - 6 months
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.
Percentage Aldofluor Positive Cells
Time frame: Baseline - 6 months
The 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundAbstract 10678: Increase in the Number of Circulating Primordial Cells is Associated With Improved Left Ventricular Function in Dilated Cardiomyopathy Nkechinyere N Ijioma, Philip F Binkley, and Amanda Lesinski Originally published27 Mar 2018Circulation. 2013;128:A10678
- Individual participant dataSharing planned: Yes. available through request to the principal investigator; has been presented as an abstract but not a published paper
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Binkley, MD, MPH principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Atorvastatin Calcium in people with Cardiovascular Disease and Cardiomyopathy, run by Philip Binkley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Endothelial Progenitor Cells (time frame: Baseline - 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00701220, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.