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AC6 Gene Transfer for CHF

NCT00787059 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-02-09

No results posted yet for this study

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. 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.

Conditions

  • Congestive Heart Failure

Interventions

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

DRUG

Sucrose (3%)

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Renova Therapeutics

    collaborator INDUSTRY

  • Hammond, H. Kirk, M.D.

    lead INDIV

Principal Investigators

  • H. Kirk Hammond, MD · UCSD; VA San Diego Healthcare System; Veterans Medical Research Foundation

  • William Penny, MD · UCSD; VA San Diego Healthcare System; Veteran's Medical Research Foundation

  • Jay H Traverse, MD · Minneapolis Heart Institute Foundation

  • Clyde W Yancy, MD · Bluhm Cardiovascular Institute, Northwestern Memorial Hospital

  • Matthew W Watkins, MD · Fletcher Allen Health Care, University of Vermont

  • Eric D Adler, MD · University of California, San Diego

  • David R Murray, MD · University of Wisconsin, Madison

  • Amit Patel, MD · University of Utah Health Care, Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-01-31
Completion
2017-11-16

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787059 on ClinicalTrials.gov