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| Sponsor: | Veterans Medical Research Foundation |
|---|---|
| Collaborator: |
National Heart, Lung, and Blood Institute (NHLBI) |
| Information provided by (Responsible Party): | Veterans Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00787059 |
Purpose
This research study is designed to determine: 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 extensive animal experiments, it was found that increased amounts of AC6 protein in heart cells appeared to make the heart pump more vigorously.
| Condition | Intervention | Phase |
|---|---|---|
|
Congestive Heart Failure |
Drug: Ad5.hAC6 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Phase I/II Study AC6 Gene Transfer for Congestive Heart Failure |
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ad5.hAC6
Will receive intracoronary adenovirus encoding human adenylyl cyclase type 6
|
Drug: Ad5.hAC6
Intracoronary delivery of Ad5.hAC6 or sucrose solution (placebo) in 3:1 randomization (Ad5.hAC6 : placebo) with dose escalation, starting at 3.2 x 10^9 vp to 3.2 x 10^12 vp in 6 dose groups
|
|
Placebo Comparator: sucrose solution
Will receive intracoronary sucrose solution
|
Drug: Ad5.hAC6
Intracoronary delivery of Ad5.hAC6 or sucrose solution (placebo) in 3:1 randomization (Ad5.hAC6 : placebo) with dose escalation, starting at 3.2 x 10^9 vp to 3.2 x 10^12 vp in 6 dose groups
|
This research study is designed to determine: 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 extensive animal experiments, it was found that increased amounts of AC6 protein in heart cells appear to make the heart pump more vigorously.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| Contact: H. Kirk Hammond, MD | 858-642-3542 | khammond@ucsd.edu |
| Contact: Eileen M D'Souza | 858-642-3542 | edsouza@vapop.ucsd.edu |
| United States, California | |
| VA San Diego Healthcare System | Recruiting |
| San Diego, California, United States, 92161 | |
| Contact: H. Kirk Hammond, MD 858-642-3542 khammond@ucsd.edu | |
| Contact: Eileen M D'Souza 858-642-3542 edsouza@vapop.ucsd.edu | |
| Principal Investigator: William Penny, MD | |
| Sub-Investigator: Alan Maisel, MD | |
| Sub-Investigator: Denise Barnard, MD | |
| Sub-Investigator: Dan Blanchard, MD | |
| Sub-Investigator: Robert S Ross, MD | |
| United States, Minnesota | |
| Minneapolis Heart Institute Foundation | Recruiting |
| 920 East 28th Street, Suite 100, Minneapolis, Minnesota, United States, 55407 | |
| Contact: Timothy D Henry, MD 612-863-7372 henry003@umn.edu | |
| Contact: Susan Jagger, RN, BSN, CCRC 612-863-7065 Susan.Jagger@allina.com | |
| Principal Investigator: Timothy D Henry, MD | |
| Study Director: | H. Kirk Hammond, MD | UCSD; VA San Diego Healthcare System; Veterans Medical Research Foundation |
| Principal Investigator: | William Penny, MD | UCSD; VA San Diego Healthcare System; Veteran's Medical Research Foundation |
| Principal Investigator: | Timothy D Henry, MD | Minneapolis Heart Institute Foundation |
More Information
| Responsible Party: | Veterans Medical Research Foundation |
| ClinicalTrials.gov Identifier: | NCT00787059 History of Changes |
| Other Study ID Numbers: | 365, P01HL066941 |
| Study First Received: | November 6, 2008 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Adenylyl Cyclase AC6 adenovirus gene therapy |
congestive heart failure intracoronary nitroprusside |
|
Heart Failure Heart Diseases Cardiovascular Diseases |