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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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.

This study is looking into a new treatment called VEGF-D for people who suffer from severe and persistent chest pain, known as refractory angina. This type of angina doesn't respond well to usual treatments. The researchers want to find out if this new therapy can help improve how far people can walk and reduce their symptoms. It's a 'Phase II' study, which means it's an early stage of testing in humans to see if the treatment works and is safe. Some participants will receive the new treatment, while others will get a 'dummy' treatment (placebo) to fairly compare the effects. The study also hopes to prove that the treatment could be a good value for the health service.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Pohjois-Savon hyvinvointialue
Enrolment target
39
Start
29 May 2024

What is this study about?

This study is exploring a new way to treat refractory angina, a type of severe chest pain that doesn't get better with standard medicines or treatments. People with refractory angina often find it hard to do everyday activities because of their chest pain. The new treatment being tested uses something called VEGF-D, which aims to help the heart recover or regenerate. Think of it like trying to mend or grow new connections in the heart muscle to improve blood flow and reduce pain.

The main goal of this research is to see if this new VEGF-D treatment can make a real difference in people's lives. Specifically, the doctors want to check two things: first, if people can walk further without pain after receiving the treatment (measured by a 6-minute walking test), and second, if their chest pain symptoms improve as judged by a widely used scale called the Canadian Cardiovascular Society (CCS) class. They hope these improvements will show that the new treatment is effective.

This is a 'Phase II' study, which is an important step in developing new medicines. It means the treatment has already been shown to be safe in a small group of people, and now researchers are looking more closely at its effectiveness and safety in a larger group. By comparing the new treatment to a 'dummy' treatment (placebo), they can be sure that any benefits seen are genuinely due to the VEGF-D and not just other factors.

Key takeaways

  • This study is for severe chest pain (refractory angina).
  • It's testing a new treatment called VEGF-D.
  • Aims to improve walking ability and reduce chest pain.
  • Compared to a 'dummy' treatment (placebo).
  • Open to adults aged 18 and over, both men and women.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women are welcome to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you at least 18 years old?
  2. Do you have severe and ongoing chest pain (refractory angina)?
  3. Are you able to attend regular study appointments?
  4. Are you willing to potentially receive a dummy treatment?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new VEGF-D treatment or a dummy treatment (placebo). Neither you nor your study doctor will know which one you are getting. Throughout the study, you will have regular visits with the research team. These visits will include checks on your health, blood tests, and assessments to measure your walking distance (the 6-minute walking test) and how your chest pain symptoms are changing. The exact number of visits and the total length of your participation will be explained in detail by the study team, but typically, these kinds of studies involve several months of follow-up.

Potential risks and benefits

Taking part in this study might offer the potential benefit of improving your chest pain symptoms and your ability to be active. However, as with any new treatment, there could be risks or side effects, which the study team will explain fully. You are free to withdraw from the study at any time, for any reason, without it affecting your usual médical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Denmark
  • Unverified
    Finland

Common questions

What is refractory angina?

It's a type of severe chest pain caused by heart disease that doesn't get better with standard treatments like medicines or procedures.

What is VEGF-D?

VEGF-D is a new treatment being tested in this study. It's meant to help the heart muscle recover or improve its blood supply.

What does 'placebo-controlled' mean?

It means some people will get the new treatment, and others will get a 'dummy' treatment that looks the same but contains no active medicine. This helps doctors see if the new treatment really works.

What is a '6-minute walking test'?

It's a simple test where you walk as far as you can in 6 minutes. It helps doctors measure how your ability to be active changes over time.

How long will the study last if I join?

The total duration of your involvement, including follow-up, will be fully explained by the study team. It typically involves several months of regular check-ups.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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