VEGF-D gene therapy in severe coronary artery disease. Phase II clinical trial(ReGenHeart).
- Conditions
- Clinical development and proof of principle testing of new regenerative VEGF-D therapy for cost-effective treatment of refractory angina.A phase II randomized, double-blinded, placebo-controlled study.Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2024-512255-20-00
- Lead Sponsor
- Pohjois-Savon hyvinvointialue
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 45
Informed consent signed, Age > 30 but = 85 years, Significant angina pectoris (CCS 2-3) despite of optimal medication, Significant stenosis (= 60%) in coronary angiography (= 12 months), Contraindication to CABG or PCI due to diffuse or distal stenosis, chronic total occlusion, vessels with difficult anatomy, stenosis with severe calcifications and stenosis in small vessels (<2.5 mm), Angina pectoris or equivalent symptoms in the 6-minute walking exercise test, Left ventricle wall = 8 mm detected by transthoracic echocardiography (treatment area)
Women of childbearing potential, Acute infection, Immunosuppressive medication, Significant impairment of left ventricular function (EF < 25%), Symptomatic congestive heart failure (NYHA 3-4), Hemodynamically significant (grade 3-4/4) aortic or mitral regurgitation or other heart disease needing surgery, Recent (< 3 months) acute coronary syndrome or myocardial infarction (elevated CK-MB or cardiac troponin), PCI, CABG or TIA/stroke, Current or suspected malignancy, Diabetes mellitus with severe complications such as proliferative diabetic retinopathy or nephropathy with renal insufficiency (see below), Clinically significant anemia (hemoglobin count < 120 mg/l in male, < 110 mg/l in female; hematocrit < 0.36), Leukopenia (b-leukocyte count < 3.0x109/l), leukocytosie count > 12.0x109/l) or thrombocytopenia (b-thrombocyte count < 100x109/l), Renal insufficiency (P-creatinine > 160 mg/l), Liver insufficiency (P-alanine aminotransferase or P-alkaline phosphatase over 2 x normal), Hematuria of unknown origin, Severe hypertension (systolic blood pressure > 200 mmHg or diastolic blood pressure > 110 mmHg) or significant hypotension (systolic blood pressure < 90 mmHg), Significant obesity (BMI > 35)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to evaluate the safety and efficacy of <br>catheter mediated AdVEGF-D regenerative gene transfer in patients with refractory angina to whom revascularization cannot be performed.;Secondary Objective: The study also investigates the effect of VEGF-D-therapy on myocardial perfusion, patients' symptoms, quality of life and safety of treatment.;Primary end point(s): Improvement of functional capacity using 6-minute walking test, Improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Improvement of functional capacity using 6-minute walking test;Secondary end point(s):Improvement of symptoms assessed by Canadian Cardiovascular Society (CCS) class;Secondary end point(s):Increase in myocardial perfusion