AC6 Gene Transfer for CHF
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00787059 |
Recruitment Status :
Completed
First Posted : November 7, 2008
Last Update Posted : February 9, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Congestive Heart Failure | Drug: Ad5.hAC6 Drug: Sucrose (3%) | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 56 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study AC6 Gene Transfer for Congestive Heart Failure |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | November 16, 2017 |
Arm | Intervention/treatment |
---|---|
Experimental: Ad5.hAC6
Will receive intracoronary adenovirus encoding human adenylyl cyclase type 6
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Drug: Ad5.hAC6
Intracoronary delivery of test substance in 3:1 randomization (Ad5.hAC6 : placebo) with dose escalation, starting at 3.2 x 10^9 vp to 10^12 vp in 5 dose groups |
Placebo Comparator: sucrose solution
Will receive intracoronary sucrose solution
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Drug: Sucrose (3%) |
- Combined: a) Exercise treadmill time; b) LV function by echocardiography before and during dobutamine infusion; c) Rate of LV pressure development and decline (dP/dt and -dP/dt) before and during dobutamine infusion. [ Time Frame: Before, 4w, 12w ]
- Symptoms (KCCQ); hemodynamics; ICD discharge frequency [ Time Frame: Before, 4w, 12 w ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
- Male or non-pregnant female patients aged 18-80 years of age
- ≥3-month history of heart failure
- Compensated (stable) CHF not on intravenous inotropes, vasodilators or diuretics, on optimal medical and device therapy as defined by AHA/ACC Guidelines
- LV ejection fraction (on optimal therapy) no greater than 40%
- Implanted cardiac defibrillator
- At least one major coronary artery (or graft) with <50% proximal obstruction
- Patients unable to walk (spinal injury, orthopedic problems) can be enrolled if all other criteria are met.
- 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 12w after test substance administration if the female partner is of child-bearing capacity.
- Subjects willingly provide informed consent consistent with ICH-GCP guidelines
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 stress echocardiography or jeopardized viable myocardium >15% on perfusion imaging.
- ≥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
- 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 hemodialysis within 12 months or estimated glomerular filtration rate (EGFR) <30 ml/min. On online EGFR calculator that uses sex, age, body weight and serum creatinine is available at: www.kidney.org/professionals/kdoqi/gfr_calculator.cfm. Use the higher of two EGFR results, which are based upon MDRD and CKD-EPI formulas.
- CVA or TIA <6 months prior to enrollment
- Patients who are immunosuppressed by medicines (corticosteroids, methotrexate, cyclophosphamide, cyclosporine), illnesses (AIDS, HIV), or neutrophil count <1000/mm3
- Patients receiving other investigational drug therapy within 30 days of enrollment including gene transfer
- Patients with diseases other than CHF that, in the opinion of the investigator, put the subject at risk or adversely affect the results

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00787059
United States, California | |
University of California, San Diego | |
San Diego, California, United States, 92037 | |
VA San Diego Healthcare System | |
San Diego, California, United States, 92161 | |
United States, Illinois | |
Northwestern University Feinberg School of Medicine | |
Chicago, Illinois, United States, 60611 | |
United States, Minnesota | |
Minneapolis Heart Institute Foundation | |
Minneapolis, Minnesota, United States, 55407 | |
United States, Utah | |
University of Utah Health Care, Utah | |
Salt Lake City, Utah, United States, 84132 | |
United States, Vermont | |
Fletcher Allen Health Care | |
Burlington, Vermont, United States, 05401 | |
United States, Wisconsin | |
University of Wisconsin-Madison | |
Madison, Wisconsin, United States, 53792 |
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: | Jay H Traverse, MD | Minneapolis Heart Institute Foundation | |
Principal Investigator: | Clyde W Yancy, MD | Bluhm Cardiovascular Institute, Northwestern Memorial Hospital | |
Principal Investigator: | Matthew W Watkins, MD | Fletcher Allen Health Care, University of Vermont | |
Principal Investigator: | Eric D Adler, MD | University of California, San Diego | |
Principal Investigator: | David R Murray, MD | University of Wisconsin, Madison | |
Principal Investigator: | Amit Patel, MD | University of Utah Health Care, Utah |
Responsible Party: | Hammond, H. Kirk, M.D. |
ClinicalTrials.gov Identifier: | NCT00787059 |
Other Study ID Numbers: |
365 P01HL066941 ( U.S. NIH Grant/Contract ) |
First Posted: | November 7, 2008 Key Record Dates |
Last Update Posted: | February 9, 2018 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | The trial remains blinded |
Adenylyl Cyclase AC6 adenovirus gene therapy |
congestive heart failure intracoronary nitroprusside |
Heart Failure Heart Diseases Cardiovascular Diseases |