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Gene Therapy Study for Severe Coronary Artery Disease Using AdsVEGF-D Delta N Delta C in Patients with Refractory Angina

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a new treatment for people with refractory angina, a condition where patients experience chest pain due to reduced blood flow to the heart, and traditional treatments like surgery or angioplasty are not possible. The treatment being tested is called AdsVEGF-D Delta N Delta C, which is a type of gene therapy. This therapy uses a modified virus, known as an adenovirus vector, to deliver a specific gene called vascular endothelial growth factor D (VEGF-D) directly to the heart. This gene is intended to help improve blood flow by encouraging the growth of new blood vessels.

The purpose of the study is to evaluate the safety and effectiveness of this gene therapy in patients with severe coronary artery disease who cannot undergo revascularization procedures. Participants in the study will receive either the gene therapy or a placebo, and neither the participants nor the researchers will know who receives which treatment. The treatment is administered through an injection directly into the heart.

Throughout the study, participants will be monitored to assess improvements in their ability to perform physical activities, such as walking, and any changes in their symptoms. The study aims to determine if the gene therapy can enhance the heart's blood supply and improve the quality of life for those with refractory angina. The trial is expected to continue until the end of 2027.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have signed an informed consent form. This indicates understanding and agreement to participate in the trial.
Eligibility criteria include being between 30 and 85 years old, having significant angina pectoris despite optimal medication, and having specific conditions related to coronary artery disease.
Step 2
Initial assessment
An initial assessment is conducted to confirm eligibility. This includes a coronary angiography showing significant stenosis and a transthoracic echocardiography to measure the left ventricle wall.
Step 3
Treatment administration
The treatment involves an injection of AdsVEGF-D Delta N Delta C or a placebo. This is administered intracardially, meaning directly into the heart.
The purpose of the treatment is to evaluate the safety and effectiveness of the gene therapy in improving symptoms of refractory angina.
Step 4
Monitoring and follow-up
Patients are monitored for changes in their condition. This includes assessing functional capacity through a 6-minute walking test and evaluating symptoms using the Canadian Cardiovascular Society (CCS) class.
Secondary assessments may include measuring myocardial perfusion, which is the blood flow to the heart muscle.
Step 5
Completion of the study
The study is expected to conclude by December 31, 2027. At the end of the study, the collected data will be analyzed to determine the effectiveness and safety of the treatment.

Who can join the trial?

7 criteria

Sign an informed consent, which means you agree to participate after understanding the study details.
Be between the ages of 31 and 85 years old.
Have significant angina pectoris, which is chest pain due to reduced blood flow to the heart, even with the best possible medication.
Have a significant stenosis, meaning a narrowing of the coronary arteries by 60% or more, as shown in a heart imaging test done within the last 12 months.
Cannot have certain heart procedures like CABG (Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention) due to specific conditions like widespread or difficult-to-reach artery narrowing, complete blockage, or severe artery hardening.
Experience chest pain or similar symptoms during a 6-minute walking test.
Have a left heart wall thickness of 8 mm or more, as seen in a heart ultrasound test.

Who cannot join the trial?

10 criteria

Patients who have had a recent heart attack or stroke cannot participate.
Individuals with severe heart failure, which means the heart is not pumping blood as well as it should, are excluded.
People with uncontrolled high blood pressure, meaning their blood pressure is too high despite treatment, are not eligible.
Patients with severe kidney disease, where the kidneys are not working properly, cannot join the study.
Individuals with active infections, meaning they currently have an infection, are excluded.
People with a history of cancer within the last five years, except for certain skin cancers, cannot participate.
Patients who are pregnant or breastfeeding are not eligible for the study.
Individuals with known allergies to the study medication or its components cannot join.
People who are participating in another clinical trial at the same time are excluded.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.

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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

AdVEGF-D is a gene therapy being tested for its ability to help treat patients with refractory angina, a condition where the heart does not get enough blood and oxygen, causing chest pain. This therapy involves using a catheter to deliver a gene that may help improve blood flow in the heart, potentially providing relief for patients who cannot undergo traditional revascularization procedures.

Adenovirus Vector Serotype 5 Containing The Vascular Endothelial Growth Factor D Isoform (Preprocessed Short Form)

What is already known about the treatment

AdVEGF-D – This medication is administered through a catheter, specifically designed for gene transfer in patients with refractory angina, a condition where traditional revascularization is not possible. Currently, it is in the clinical trial phase, being evaluated for its safety and effectiveness in treating this condition. The main therapeutic indication is to provide a new regenerative therapy for patients suffering from refractory angina. At the molecular level, AdVEGF-D works by promoting the growth of new blood vessels through the delivery of the VEGF-D gene, which is intended to improve blood flow to the heart. It is classified pharmacologically as a gene therapy product.

Investigated diseases

Refractory Angina – Refractory angina is a chronic condition characterized by persistent chest pain due to inadequate blood flow to the heart muscle, despite optimal medical therapy and revascularization procedures. It occurs when the coronary arteries are unable to supply sufficient oxygen-rich blood to meet the heart's demands. Patients with this condition often experience frequent episodes of chest pain, which can significantly impact their quality of life. The pain is typically triggered by physical exertion or emotional stress and may be relieved by rest or medication. Over time, the condition can lead to a decrease in physical activity levels and an increased reliance on medications to manage symptoms.