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

Phase 1

• Conditions: Ischemic Heart Disease
• Interventions: Drug: Ad-HGF

• Registration Number: NCT01925352
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

Brief Summary

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

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 Timeline

• Study Start: 2012-11
• Status Verified: 2013-08
• Study First Submitted: 2013-08-15
• Study First Submitted QC: 2013-08-16
• Study First Posted: 2013-08-19
• Last Update Submitted: 2013-08-19
• Last Update Posted: 2013-08-20
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ad-HGF	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with death,new myocardial infarction or stroke	6 months after treatment

Secondary Outcome Measures

Name	Time	Method
left ventricular ejection fraction (LVEF)	6 months after treatment

Trial Locations

Locations (1)

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China