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VEGF-D gene therapy in severe coronary artery disease. Phase II clinical trial (ReGenHeart).
EU CTIS ID: 2024-512255-20-00
What this study is testing
The purpose of the study is to evaluate the safety and efficacy of catheter mediated AdVEGF-D regenerative gene transfer in patients with refractory angina to whom revascularization cannot be performed.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.