Clinical trial NCT01925352: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Ischemic Heart Disease
Keywords: ischemic heart disease
adenovirus
hepatocyte growth factor
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Academy Military Medical Science, China
First posted: 2013-08-19
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of participants with death,new myocardial infarction or stroke
timeFrame: 6 months after treatment
Secondary outcomes:
measure: left ventricular ejection fraction (LVEF)
timeFrame: 6 months after treatment
Other outcomes:
measure: tumor markers of blood
timeFrame: 6 months after treatment
Locations:
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zhijian Yang, PhD.
role: PRINCIPAL_INVESTIGATOR
References: