Ischemic Congestive Heart Failure (CHF)Phase 1NCT00279539
Stem Cell Mobilization and VEGF Gene Transfer for Heart Failure
A Phase 1 study testing Vascular Endothelial Growth Factor (VEGF1) in people with Ischemic Congestive Heart Failure (CHF), run by Losordo, Douglas, M.D..
Trial summary
The purpose of this study is to evaluate the safety and bioactivity of intramyocardial gene transfer using VEGF (vascular endothelial growth factor) in patients with ischemic heart failure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ischemic Congestive Heart Failure (CHF)
- What is being tested?
- Vascular Endothelial Growth Factor (VEGF1)
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to not given
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Be > 21 years old.
- Have mild or moderate (NYHA Class II or III) CHF secondary to ischemic heart disease.
- Have left ventricular ejection fraction <40%.
- Patients must have total occlusion of one or more extramural coronary arteries demonstrated by diagnostic angiography within 6 months prior to study enrollment.
- Patients must be on a stable cardiac medical regimen (i.e. the same anti-anginal and anti-congestive medications) for 1 month prior to determination of their baseline functional status. The judgment regarding the optimal medical regimen for each individual subject will have been made by the referring cardiologist.
- Subjects must be identified as non-candidates for conventional revascularization by their referring cardiologist.
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- Have serum B-type Natriuretic Peptide (BNP) level >100 pg/ml.
- Women of childbearing potential must agree not to become pregnant during the course of the study. Nonsterile men participating in the study must also agree not to impregnate their partners.
- Have the ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
Who cannot join
- Have a history of alcohol or drug abuse within 3 months of screening.
- Subjects with evidence (clinical, laboratory, or imaging) or history of neoplasm, or, cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma).
- Have evidence of moderate to severe proliferative retinopathy on fundoscopic examination by an ophthalmologist.
- History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency(>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
- Coronary revascularization procedures within 6 months of study enrollment.
- Documented stroke or transient ischemic attack (TIA) within 60 days of study enrollment.
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- Severe co-morbidity associated with a reduction in life expectancy of less than 1 year, such as chronic medical illness (i.e. severe chronic obstructive pulmonary disease, renal failure or cancer).
- Joint or peripheral vascular disease that severely limit treadmill walking.
- Chronic obstructive pulmonary disease that severely limits walking or FEV1.0<30% predicted.
- Have idiopathic or non-ischemic heart failure.
- Have NYHA Class IV heart failure.
- Have or require mechanical ventricular support
- Had surgical heart failure treatments, including left ventricular reconstructive surgery (Dor procedure, cardiomyoplasty, LV banding, etc.)
- Implantation of biventricular pacemaker within 90 days of study treatment.
- Be pregnant or lactating.
- Have a history of an allergy to penicillin.
- Have sickle cell disease.
- Have an untreatable coagulopathy.
- Have a serum creatinine >3.5 mg/dL.
- Have any clinically significant abnormality in liver function or other clinical chemistry or hematology test (defined as a value more than 2 times the upper limit of the normal range for that value).
- Previous enrollment in the study.
- Be unsuitable for participation in the study, in the opinion of the Investigator.
About this study
Official title: phVEGF165 GENE TRANSFER TO PROMOTE ANGIOGENESIS IN PATIENTS WITH ISCHEMIC HEART FAILURE
The purpose of this study is to evaluate the safety and bioactivity of intramyocardial gene transfer using VEGF (vascular endothelial growth factor) in patients with ischemic heart failure. The research treatment of this CHF study will involve the use of an intramuscular injection with a catheter inserted in through the groin to transfer a type of DNA (phVEGF165 gene) to the wall of the heart. Genes (which are part of the DNA molecules) carry instructions to allow the cells to produce specific proteins. Gene transfer or treatment with DNA (a necessary part of all cells) is being studied for the treatment of patients with heart failure. This research therapy, which is experimental and not proven, is designed to try to grow new blood vessels to improve blood flow to areas of the heart that are not receiving enough blood.
DNA is present in all cells and provides the instructions for making proteins. After delivering a piece of DNA containing the vascular endothelial growth factor 1 (VEGF-1) gene (the product being studied) into cells, the cells may produce a specific protein called vascular endothelial growth factor 1 (VEGF-1). Animal studies have indicated that the VEGF-1 protein may cause new blood vessels to grow. The Vascular Endothelial Growth Factor Gene (ph VEGF 165) is found on the VEGF DNA. Experiments performed in animals show that once in the heart wall, the DNA directs the cells of the heart muscle to make the VEGF protein. VEGF 165 is a protein that has been shown to stimulate cells (known as endothelial cells), which form the inner lining of blood vessels. This protein causes cells to divide and grow, thereby forming new blood vessels. It is anticipated that this new blood supply may help the heart pump the blood more effectively and relieve some heart failure symptoms. We do not yet have enough information to know what will happen in humans, that is why we are doing this research.
Read more
After gene transfer we will begin a process to help move some of the stem cells from the bone marrow into the blood circulation. Subjects will be given the drug called G-CSF (a drug used to move cells from the bone marrow into the blood stream). Stem cells are young cells produced by bone marrow (the spongy cavity in the center of large bones) that can develop into blood cells or other types of cells. This medication triggers the movement of stem cells out of the bone marrow and into the blood stream. Before being released into the blood stream, stem cells receive signals that direct them to become specific types of cells such as CD34+ cells (endothelial progenitor cells). CD34+ cells that move to or are in the area of damaged heart tissue may promote growth of new blood vessels that supply blood and nutrients and thereby improve the chance of survival of heart tissue, improve heart function, and possibly have a long-term benefit.
We will be recruiting 12 subjects for this study. There will be no randomization and no placebo group. Once eligibility in the research study has been determined all subjects will be treated with the VEGF and G-CSF.
- Conditions
- Ischemic Congestive Heart Failure (CHF)
- Being tested
- Vascular Endothelial Growth Factor (VEGF1)
- Keywords
- Cardiovascular, Gene Therapy, DNA, Stem Cells, Congestive Heart Failure, Coronary Artery Disease, CHF, Cardiomyopathy
- Medical subject headings
- Heart Failure, Coronary Artery Disease, Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular Endothelial Growth Factor (VEGF1)Genetic
What is being measured
The primary outcome is the main question the study is designed to answer.
LVEF
Left ventricular ejection fraction measured by echo
Measured: 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 Jan 2006 (estimated)
- Study startJul 2008
Why it stopped: Study never started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Congestive Heart Failure (CHF)Studies 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 1
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Losordo, Douglas, M.D.
- Investigators
- Dr. Douglas W. Losordo, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00279539
- Sponsor's protocol ID
- BB-IND 10442
- Status last verified
- Jun 2009
- First submitted
- 17 Jan 2006
- Last updated
- 1 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- phVEGF165 GENE TRANSFER TO PROMOTE ANGIOGENESIS IN PATIENTS WITH ISCHEMIC HEART FAILURE
- ClinicalTrials.gov ID
- NCT00279539
- Acronym / sponsor ID
- BB-IND 10442
- Conditions
- Ischemic Congestive Heart Failure (CHF)
- Keywords
- Cardiovascular, Gene Therapy, DNA, Stem Cells, Congestive Heart Failure, Coronary Artery Disease, CHF, Cardiomyopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Losordo, Douglas, M.D.
- Study start
- Jul 2008
- First posted
- 19 Jan 2006 (estimated)
- Results
- Not posted in the source record
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 evaluate the safety and bioactivity of intramyocardial gene transfer using VEGF (vascular endothelial growth factor) in patients with ischemic heart failure. The research treatment of this CHF study will involve the use of an intramuscular injection with a catheter inserted in through the groin to transfer a type of DNA (phVEGF165 gene) to the wall of the heart. Genes (which are part of the DNA molecules) carry instructions to allow the cells to produce specific proteins. Gene transfer or treatment with DNA (a necessary part of all cells) is being studied for the treatment of patients with heart failure. This research therapy, which is experimental and not proven, is designed to try to grow new blood vessels to improve blood flow to areas of the heart that are not receiving enough blood.
DNA is present in all cells and provides the instructions for making proteins. After delivering a piece of DNA containing the vascular endothelial growth factor 1 (VEGF-1) gene (the product being studied) into cells, the cells may produce a specific protein called vascular endothelial growth factor 1 (VEGF-1). Animal studies have indicated that the VEGF-1 protein may cause new blood vessels to grow. The Vascular Endothelial Growth Factor Gene (ph VEGF 165) is found on the VEGF DNA. Experiments performed in animals show that once in the heart wall, the DNA directs the cells of the heart muscle to make the VEGF protein. VEGF 165 is a protein that has been shown to stimulate cells (known as endothelial cells), which form the inner lining of blood vessels. This protein causes cells to divide and grow, thereby forming new blood vessels. It is anticipated that this new blood supply may help the heart pump the blood more effectively and relieve some heart failure symptoms. We do not yet have enough information to know what will happen in humans, that is why we are doing this research.
After gene transfer we will begin a process to help move some of the stem cells from the bone marrow into the blood circulation. Subjects will be given the drug called G-CSF (a drug used to move cells from the bone marrow into the blood stream). Stem cells are young cells produced by bone marrow (the spongy cavity in the center of large bones) that can develop into blood cells or other types of cells. This medication triggers the movement of stem cells out of the bone marrow and into the blood stream. Before being released into the blood stream, stem cells receive signals that direct them to become specific types of cells such as CD34+ cells (endothelial progenitor cells). CD34+ cells that move to or are in the area of damaged heart tissue may promote growth of new blood vessels that supply blood and nutrients and thereby improve the chance of survival of heart tissue, improve heart function, and possibly have a long-term benefit.
We will be recruiting 12 subjects for this study. There will be no randomization and no placebo group. Once eligibility in the research study has been determined all subjects will be treated with the VEGF and G-CSF.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Be > 21 years old.
- Have mild or moderate (NYHA Class II or III) CHF secondary to ischemic heart disease.
- Have left ventricular ejection fraction <40%.
- Patients must have total occlusion of one or more extramural coronary arteries demonstrated by diagnostic angiography within 6 months prior to study enrollment.
- Patients must be on a stable cardiac medical regimen (i.e. the same anti-anginal and anti-congestive medications) for 1 month prior to determination of their baseline functional status. The judgment regarding the optimal medical regimen for each individual subject will have been made by the referring cardiologist.
Key exclusion criteria (22 listed)
- Have a history of alcohol or drug abuse within 3 months of screening.
- Subjects with evidence (clinical, laboratory, or imaging) or history of neoplasm, or, cancer recurrence within the past 5 years (other than non-melanoma skin cancer or in situ cervical carcinoma).
- Have evidence of moderate to severe proliferative retinopathy on fundoscopic examination by an ophthalmologist.
- History of severe aortic stenosis (aortic valve area < 1.0 cm2) or insufficiency(>2+); severe mitral stenosis (mitral valve area <1.5 cm2); or severe mitral insufficiency(>2+).
- Coronary revascularization procedures within 6 months of study enrollment.
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 |
|---|---|---|
| Vascular Endothelial Growth Factor (VEGF1) | Genetic | – |
Primary outcome
LVEF
Time frame: 6 months
Left ventricular ejection fraction measured by echo
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2015.
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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.
Dr. Douglas W. Losordo, M.D. principal investigator
Northwestern University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vascular Endothelial Growth Factor (VEGF1) in people with Ischemic Congestive Heart Failure (CHF), run by Losordo, Douglas, M.D..
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 9 inclusion and 22 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: withdrawn, as of the sponsor's last update on 1 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
LVEF (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2015.