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View Clinical Trial (Medical Research Study)
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AC6 Gene Transfer for Congestive Heart Failure - NCT00787059-92161 (Clinical Trial 251694)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy251694.aspx
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** Please review additional "Nearby Studies" on right ----->
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92161 |
| Conditions: |
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Congestive Heart Failure |
| Purpose: |
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Dr. H. Kirk Hammond and associates are conducting a research study to find out 1) whether
gene transfer using an agent called Ad5.hAC6 (adenovirus-5 encoding human adenylyl cyclase
type 6) can be given safely to patients with congestive heart failure (CHF) and 2) whether
this agent may be of benefit in heart failure. Gene transfer is an idea in which genes are
introduced into cells and the cells then produce the specific protein that the gene directs,
in this case, a protein known as adenylyl cyclase type 6 (AC6). The gene is carried into
the heart cells by a modified virus. The virus that is modified is an adenovirus (Ad5), a
virus that sometimes causes a brief cold. In an animal experiment, it was found that
increased amounts of AC6 protein in heart cells appeared to make the heart pump more
vigorously.
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| Study summary: |
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| Criteria: |
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Patients with severe but stable low ejection fraction heart failure (see inclusion
criteria below) are candidates for enrollment in the proposed trial. LV ejection fraction
can be determined by echocardiography, radionuclide or LV angiography within 12-months of
enrollment, and should be assessed when the patient is on optimal therapy (referring
cardiologist opinion) for at least 14 days. Patients will be candidates for diagnostic
cardiac catheterization to rule out treatable causes of heart failure or will be willing
to undergo elective catheterization for this study. All patients disease will undergo
dobutamine echocardiography prior to enrollment to assess the extent of jeopardized viable
myocardium.
Inclusion Criteria
- Male or non-pregnant female patients aged 18 to 80 years of age ≥3-month history of
heart failure
- Compensated (stable) CHF not on intravenous inotropes, vasodilators or diuretics, on
optimal medical therapy as defined by AHA/ACC Guidelines
- LV ejection fraction (on optimal therapy) of ≤35%
- Implantable cardiac defibrillator (ICD)
- At least one major coronary artery (or graft) with <50% proximal obstruction
- Women of child-bearing capacity must have a negative pregnancy test within 2 days of
test substance administration, and female and male patients must be willing to use
birth control during sex for 6w after test substance administration if the female
partner is of child-bearing capacity.
Exclusion Criteria
- Unstable or Class IV angina
- Coronary revascularization planned or predicted in next 6 months
- Ischemic myocardium in 3 or more regions of a single perfusion bed, as assessed by
dobutamine echocardiography
- ≥50% occlusion of an "unprotected" left main coronary artery. If arterial or venous
conduits provide blood flow to the distal left coronary circulation (ie, patent
bypass grafts) then left main disease is "protected" and such patients are not
excluded. The cardiologist performing the cardiac catheterization will make these
decisions.
- 2° AV block (Mobitz 2) or 3° AV block unless pacemaker is present
- Hospitalization for CHF requiring intravenous inotropes or vasodilators in the past 4
weeks
- History of biopsy proven myocarditis
- Myocardial infarction in previous 6 months
- Restrictive, hypertrophic or infiltrative cardiomyopathy or chronic pericarditis
angiographic contrast requiring high doses of steroid pre-treatment
- Previous or planned organ transplant recipient or donor
- Thrombocytopenia (<100,000 platelets/μl) or bleeding diathesis
- COPD requiring supplemental oxygen at home
- AST >2 times upper limit of normal or chronic liver disease such as cirrhosis or
Hepatitis C Virus (HCV). Patients with HCV are eligible only if both of two
conditions are met: a) liver function tests are normal; AND b) liver biopsy is normal
or shows only mild fibrosis.
- Current or predicted need for hemodialysis within 12 months or creatinine clearance
<30 ml/min, either estimated (MDRD equation) or measured
- CVA, TIA or RIND <6 months prior to enrollment
- Patients who are immunosuppressed by medicines (corticosteroids, methotrexate,
cyclophosphamide, cyclosporine), illnesses (AIDS, HIV), or neutrophil count
<1000/mm^3
- Patients receiving other investigational drug therapy within 30 days of enrollment
including gene transfer |
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| Study is available at: |
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VA San Diego Healthcare System
San Diego, CA 92161
United States
Primary Contact:
H. Kirk Hammond, MD
Email: khammond@ucsd.edu
Phone: 858-642-3542
Secondary Contact:
H. Kirk Hammond, MD
Email: khammond@ucsd.edu
Phone: 858-642-3542 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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