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

Ischemic Heart Disease Clinical Trial

Official title:

Phase 2 Study of Adenovirus Hepatocyte Growth Factor for Treatment of Ischemic Heart Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01925352
• Other study ID #: HIHD
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: August 15, 2013
• Last updated: August 19, 2013
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2013
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Dingguo Zhang, PhD.
• Phone: 86-25-83718836
• Email: zhdg0223[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenoviridae Infections
• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Drug:
• Ad-HGF
5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Academy Military Medical Science, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	tumor markers of blood		6 months after treatment	Yes
Primary	Number of participants with death,new myocardial infarction or stroke		6 months after treatment	Yes
Secondary	left ventricular ejection fraction (LVEF)		6 months after treatment	No