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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00787059 |
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.
Condition | Intervention | Phase |
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Congestive Heart Failure |
Drug: Ad5.hAC6 Procedure: Coronary catheterization with left and right heart catheterization |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ad5.hAC6 Gene Transfer for CHF |
Estimated Enrollment: | 72 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ad5.hAC6: Experimental
Will receive intracoronary adenovirus encoding human adenylyl cyclase type 6
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Drug: Ad5.hAC6
Intracoronary delivery of Ad5.hAC6 or PBS in 3:1 randomization with dose escalation, starting at 3.2 x 10^9 vp to 3.2 x 10^12 vp in 6 dose groups
Procedure: Coronary catheterization with left and right heart catheterization
Right heart and left heart pressures (left heart before and after dobutamine infusion) followed by intracoronary delivery of Ad5.hAC6 or PBS during intracoronary nitroprusside infusion. Right and left heart pressure recording will be performed prior to intracoronary delivery of test substance and repeated 4w after delivery.
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PBS: Placebo Comparator
Will receive intracoronary phosphate buffered saline
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Drug: Ad5.hAC6
Intracoronary delivery of Ad5.hAC6 or PBS in 3:1 randomization with dose escalation, starting at 3.2 x 10^9 vp to 3.2 x 10^12 vp in 6 dose groups
Procedure: Coronary catheterization with left and right heart catheterization
Right heart and left heart pressures (left heart before and after dobutamine infusion) followed by intracoronary delivery of Ad5.hAC6 or PBS during intracoronary nitroprusside infusion. Right and left heart pressure recording will be performed prior to intracoronary delivery of test substance and repeated 4w after delivery.
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
Exclusion Criteria
Contact: H. Kirk Hammond, MD | 858-642-3542 | khammond@ucsd.edu |
Contact: Jan M. Trausch | 858-642-3542 | jtrausch@vapop.ucsd.edu |
United States, California | |
VA San Diego Healthcare System | |
San Diego, California, United States, 92161 | |
UCSD Thornton Hospital | |
La Jolla, California, United States, 92037 |
Principal Investigator: | H. Kirk Hammond, MD | UCSD; VA San Diego Healthcare System; Veterans Medical Research Foundation |
Responsible Party: | UCSD; VA San Diego; Veterans Medical Research Foundation (VMRF) ( H. Kirk Hammond, MD ) |
Study ID Numbers: | 365, P01 HL066941 |
Study First Received: | November 6, 2008 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00787059 |
Health Authority: | United States: Food and Drug Administration |
Adenylyl Cyclase AC6 adenovirus gene therapy |
congestive heart failure intracoronary nitroprusside |
Heart Failure Heart Diseases Adenoviridae Infections Nitroprusside Dobutamine |
Cardiovascular Diseases |