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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Jiangsu Province Hospital
Sponsor:
Collaborator:
Academy Military Medical Science, China
Information provided by (Responsible Party):
zhijian yang, Jiangsu Province Hospital
ClinicalTrials.gov Identifier:
NCT01925352
First received: August 15, 2013
Last updated: August 19, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Ischemic Heart Disease
Drug: Ad-HGF
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by Jiangsu Province Hospital:

Primary Outcome Measures:
  • Number of participants with death,new myocardial infarction or stroke [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • left ventricular ejection fraction (LVEF) [ Time Frame: 6 months after treatment ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • tumor markers of blood [ Time Frame: 6 months after treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01925352

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

Locations
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
Jiangsu Province Hospital
Academy Military Medical Science, China
Investigators
Principal Investigator: Zhijian Yang, PhD. Jiangsu Province Hospital
  More Information

No publications provided

Responsible Party: zhijian yang, Professor, Jiangsu Province Hospital
ClinicalTrials.gov Identifier: NCT01925352     History of Changes
Other Study ID Numbers: HIHD
Study First Received: August 15, 2013
Last Updated: August 19, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Jiangsu Province Hospital:
ischemic heart disease
adenovirus
hepatocyte growth factor

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

ClinicalTrials.gov processed this record on September 18, 2014