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

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ClinicalTrials.gov Identifier: NCT01925352
Recruitment Status : Unknown
Verified August 2013 by zhijian yang, Jiangsu Province Hospital.
Recruitment status was:  Recruiting
First Posted : August 19, 2013
Last Update Posted : August 20, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
To explore the safety and efficiency of adenovirus-hepatocyte growth factor(Ad-HGF) treatment in ischemic heart disease.

Condition or disease Intervention/treatment Phase
Ischemic Heart Disease Drug: Ad-HGF Phase 1 Phase 2

Detailed Description:
  1. Ischemic heart disease refers to a group of closely related syndromes by an imbalance between the myocardial oxygen demand and the blood supply.
  2. 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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease
Study Start Date : November 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Ad-HGF
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.
Drug: Ad-HGF
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
Other Name: adenovirs hepatocyte growth factor

Outcome Measures

Primary Outcome Measures :
  1. Number of participants with death,new myocardial infarction or stroke [ Time Frame: 6 months after treatment ]

Secondary Outcome Measures :
  1. left ventricular ejection fraction (LVEF) [ Time Frame: 6 months after treatment ]

Other Outcome Measures:
  1. tumor markers of blood [ Time Frame: 6 months after treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

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): NCT01925352

Contact: Dingguo Zhang, PhD. 86-25-83718836 ext 6640 zhdg0223@aliyun.com

China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Dingguo Zhang, PhD    86-25-83718836 ext 6640    zhdg0223@aliyun.com   
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Academy Military Medical Science, China
Principal Investigator: Zhijian Yang, PhD. The First Affiliated Hospital with Nanjing Medical University
More Information

Responsible Party: zhijian yang, Professor, Jiangsu Province Hospital
ClinicalTrials.gov Identifier: NCT01925352     History of Changes
Other Study ID Numbers: HIHD
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: August 20, 2013
Last Verified: August 2013

Keywords provided by zhijian yang, Jiangsu Province Hospital:
ischemic heart disease
hepatocyte growth factor

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Adenoviridae Infections
Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
DNA Virus Infections
Virus Diseases
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action