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Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease

Primary Purpose

Ischemic Heart Disease

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Ad-HGF
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ischemic Heart Disease focused on measuring ischemic heart disease, adenovirus, hepatocyte growth factor

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • person with ischemic heart disease;
  • Male or female of 20 to 70 years old;
  • No blood perfusion detected in some area of heart using Single-Photon Emission Computed Tomography(SPECT) or Magnetic Resonance Imaging(MRI)
  • two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG)；Or patients refuse to perform PCI or CABG
  • LVEF is ≤45%;
  • Patients must sign approved informed consent.

Exclusion Criteria:

  • Acute myocardial infarction occured within one week
  • CABG performed within 6 months or PCI performed within 3 months
  • Patients with systemic active infection
  • Blood alanine aminotransferase (ALT)>135mmol/L or blood crea(Cr)>200umol/L or patients with chronic obstructive pulmonary disease (COPD)
  • patients with obvious bleeding tendency and blood disease
  • patients with malignant tumor or end-stage disease
  • patient anticipated life expectancy is less than 12 months
  • patient recently attended test drugs or other device research

Sites / Locations

  • Jiangsu Province HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ad-HGF

Arm Description

5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection in patients with ischemic heart disease into five left ventricular sites once.

Outcomes

Primary Outcome Measures

Number of participants with death,new myocardial infarction or stroke

Secondary Outcome Measures

left ventricular ejection fraction (LVEF)

Full Information

First Posted
August 15, 2013
Last Updated
August 19, 2013
Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Academy Military Medical Science, China
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1. Study Identification

Unique Protocol Identification Number
NCT01925352
Brief Title
Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease
Official Title
Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
Collaborators
Academy Military Medical Science, China

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment in ischemic heart disease.
Detailed Description
Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply. Gene therapy offers an attractive alternative to current pharmacologic therapies and may be beneficial in refractory disease. Gene therapy with hepatocyte growth factor induces angiogenesis, decreases apoptosis and leads to protection in the ischemic heart. In this study, we mainly explore the safety and effects of adenovirus hepatocyte growth factor for the treatment of ischemic heart disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
Keywords
ischemic heart disease, adenovirus, hepatocyte growth factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ad-HGF
Arm Type
Experimental
Arm Description
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection in patients with ischemic heart disease into five left ventricular sites once.
Intervention Type
Drug
Intervention Name(s)
Ad-HGF
Other Intervention Name(s)
adenovirs hepatocyte growth factor
Intervention Description
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Primary Outcome Measure Information:
Title
Number of participants with death,new myocardial infarction or stroke
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
left ventricular ejection fraction (LVEF)
Time Frame
6 months after treatment
Other Pre-specified Outcome Measures:
Title
tumor markers of blood
Time Frame
6 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: person with ischemic heart disease; Male or female of 20 to 70 years old; No blood perfusion detected in some area of heart using Single-Photon Emission Computed Tomography(SPECT) or Magnetic Resonance Imaging(MRI) two or more than two coronary arteries lesions were detected using coronary artery angiography and at least one coronary artery are un-suitable for percutaneous coronary intervention (PCI) or Coronary artery bypass grafting (CABG)；Or patients refuse to perform PCI or CABG LVEF is ≤45%; Patients must sign approved informed consent. Exclusion Criteria: Acute myocardial infarction occured within one week CABG performed within 6 months or PCI performed within 3 months Patients with systemic active infection Blood alanine aminotransferase (ALT)>135mmol/L or blood crea(Cr)>200umol/L or patients with chronic obstructive pulmonary disease (COPD) patients with obvious bleeding tendency and blood disease patients with malignant tumor or end-stage disease patient anticipated life expectancy is less than 12 months patient recently attended test drugs or other device research
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dingguo Zhang, PhD.
Phone
86-25-83718836
Ext
6640
Email
zhdg0223@aliyun.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhijian Yang, PhD.
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dingguo Zhang, PhD
Phone
86-25-83718836
Ext
6640
Email
zhdg0223@aliyun.com

12. IPD Sharing Statement

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Safety Study of Adenovirus Hepatocyte Growth Factor to Treat Ischemic Heart Disease

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