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AzTrials

Congestive Heart FailurePhase 1/2NCT00787059

AC6 Gene Transfer for CHF

A Phase 1/2 study testing Ad5.hAC6 and Sucrose (3%) in people with Congestive Heart Failure, run by Hammond, H. Kirk, M.D. at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Congestive Heart Failure
What is being tested?
Ad5.hAC6 and Sucrose (3%)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
7 sitesUnited States
Study dates
Jul 2010to 16 Nov 2017
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • University of Wisconsin-Madison

    Madison, Wisconsin, 53792

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • University of Utah Health Care, Utah

    Salt Lake City, Utah, 84132

  • University of California, San Diego

    San Diego, California, 92037

  • VA San Diego Healthcare System

    San Diego, California, 92161

Other trials in United States

About this study

Official title: Phase I/II Study AC6 Gene Transfer for Congestive Heart Failure

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 a process by 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.

Read the detailed description

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 a process by 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.

Being tested
Ad5.hAC6, Sucrose (3%)
Keywords
Adenylyl Cyclase, AC6, adenovirus, gene therapy, congestive heart failure, intracoronary, nitroprusside
Medical subject headings
Heart Failure, Adenoviridae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ad5.hAC6Drug

    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

  • Sucrose (3%)Drug

Study groups in NCT00787059
Study groupRoleWhat they receive
Ad5.hAC6ExperimentalWill receive intracoronary adenovirus encoding human adenylyl cyclase type 6
Receives: Drug: Ad5.hAC6
sucrose solutionPlacebo comparatorWill receive intracoronary sucrose solution
Receives: Drug: Sucrose (3%)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Before, 4w, 12w

Secondary outcomes (1)

  1. Symptoms (KCCQ); hemodynamics; ICD discharge frequency

    Measured: Before, 4w, 12 w

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2008 (estimated)
  2. Study startJul 2010
  3. Primary completionJan 2015
  4. Study completion16 Nov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00787059
Sponsor's protocol ID
365
Other IDs
P01HL066941
Status last verified
Aug 2017
First submitted
6 Nov 2008
Last updated
9 Feb 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided: The trial remains blinded

Publications

  • Hammond HK, Penny WF, Traverse JH, Henry TD, Watkins MW, Yancy CW, Sweis RN, Adler ED, Patel AN, Murray DR, Ross RS, Bhargava V, Maisel A, Barnard DD, Lai NC, Dalton ND, Lee ML, Narayan SM, Blanchard DG, Gao MH. Intracoronary Gene Transfer of Adenylyl Cyclase 6 in Patients With Heart Failure: A Randomized Clinical Trial. JAMA Cardiol. 2016 May 1;1(2):163-71. doi: 10.1001/jamacardio.2016.0008.

    PubMed 27437887

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ad5.hAC6 and Sucrose (3%) in people with Congestive Heart Failure, run by Hammond, H. Kirk, M.D. at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00787059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2018.

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