Status:
WITHDRAWN
Stem Cell Mobilization and VEGF Gene Transfer for Heart Failure
Lead Sponsor:
Losordo, Douglas, M.D.
Conditions:
Ischemic Congestive Heart Failure (CHF)
Eligibility:
All Genders
21+ years
Phase:
PHASE1
Brief 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. The resear...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00279539
Start Date
July 1 2008
Last Update
April 1 2015
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