AC6 Gene Transfer for CHF

Phase 1

Completed

• Conditions: Congestive Heart Failure
• Interventions: Drug: Sucrose (3%); Drug: Ad5.hAC6

• Registration Number: NCT00787059
• Lead Sponsor: Hammond, H. Kirk, M.D.

Brief 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.

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.

Study Timeline

• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Study Start: 2010-07
• Primary Completion: 2015-01
• Disposition First Submitted: 2016-02-18
• Disposition First Submitted QC: 2016-04-26
• Disposition First Posted: 2016-05-25
• Status Verified: 2017-08
• Study Completion: 2017-11-16
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sucrose solution	Sucrose (3%)	Will receive intracoronary sucrose solution
Ad5.hAC6	Ad5.hAC6	Will receive intracoronary adenovirus encoding human adenylyl cyclase type 6

Primary Outcome Measures

Name	Time	Method
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.	Before, 4w, 12w

Secondary Outcome Measures

Name	Time	Method
Symptoms (KCCQ); hemodynamics; ICD discharge frequency	Before, 4w, 12 w

Trial Locations

Locations (7)

University of California, San Diego; 🇺🇸 San Diego, California, United States

VA San Diego Healthcare System; 🇺🇸 San Diego, California, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States

University of Utah Health Care, Utah; 🇺🇸 Salt Lake City, Utah, United States

University of Wisconsin-Madison; 🇺🇸 Madison, Wisconsin, United States