Chronic angina pectoris is a debilitating chronic disease. Unfortunately, a subgroup of these patients suffers from refractory angina which can’t be controlled by a combination of medical therapy, angioplasty and coronary bypass surgery. Refractory angina is a substantial burden on both the individual and their healthcare system, in Europe there are at least 100,000 new cases per year, annual mortality of these patients is relatively low (<4%) thus refractory angina patients suffer multiple hospitalizations and low levels of health-related quality of life.
The ReGenHeart project is based on extensive preclinical work and a phase I safety, feasibility and dose-finding clinical study previously completed by members of the consortium. The project will conduct a multicentre, randomized, placebo controlled, double-blinded Phase II clinical study to provide proof of concept and clinical validation for a new, percutaneous, cost-efficient gene therapy for refractory angina patients. Using our optimized catheter mediated intramyocardial approach with adenovirus-mediated vascular endothelial growth factor-D (AdVEGF-D), which had never been used in man before our phase I trial, we aim to induce regenerative changes supported by therapeutic angiogenesis in the affected area of a patient's heart and, in a single procedure, reduce the burden on the individual and their health service.
The trial will be conducted in six European clinical centres in Finland, United Kingdom, Spain, Poland, Austria and Denmark. We will recruit 180 angina patients with Canadian Cardiovascular Society (CCS) class 2-3 refractory angina which will allow us to assess the benefits to patients who still have potential to respond to the regenerative therapy. Patients will be randomized 2:1 to either the gene therapy or placebo arms.
Trial follow up, at 6 and 12 months, will assess how far the trial subjects can walk in 6 minutes and also their CCS angina score and quality of life as well as through use of several advanced imaging methods.