A parallel-group low-intervention, phase IV, randomized, double-blind, placebo-controlled, single-center, national, two-arm trial to investigate efficacy and safety of Cardiodoron® in patients with functional cardiovascular disorders (FCD)
This study is investigating a medication called Cardiodoron to see if it can help people who experience symptoms related to functional cardiovascular disorders (FCD). These are heart-related symptoms that don't have a clear physical cause. The study aims to find out if Cardiodoron improves these symptoms and whether it's safe to use. We'll be comparing it against a 'dummy pill' (placebo) to get a clear picture of its effects. This is a "Phase IV" study, which means the medicine has already been approved and is being studied further in a larger group of people. Participants will be adults aged 18 and over, of any sex, living in the UK. The results will help us understand if Cardiodoron could be a useful treatment for FCD.
At a glance
What is this study about?
This research study is looking into a medication called Cardiodoron. We want to see if it can help people who have what are called 'functional cardiovascular disorders' (FCD). This simply means you might have symptoms like a racing heart, chest discomfort, or feeling dizzy, but doctors can't find a specific problem with your heart or blood vessels. These symptoms are very real and can be quite distressing.
In this study, we're carefully comparing Cardiodoron with a 'dummy pill' or 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active ingredients. This is a common and important way to make sure that any improvements we see are genuinely due to Cardiodoron, and not just because people expect to feel better. Neither you nor your study doctor will know whether you are receiving Cardiodoron or the placebo, which helps us get unbiased results.
The main goal is to understand if Cardiodoron can make your FCD symptoms less severe and improve your overall well-being and quality of life. We'll also be closely monitoring any side effects to ensure the medicine is safe. This study is taking place in the UK and welcomes adult men and women to participate. We hope the findings will provide valuable information for healthcare professionals and patients dealing with FCD.
Key takeaways
- This study explores a potential new treatment (Cardiodoron) for heart-related symptoms that don't have a clear physical cause.
- It compares Cardiodoron with a dummy pill (placebo) to ensure fair results.
- Participation involves taking medication, clinic visits, and completing questionnaires.
- The study measures changes in symptoms, quality of life, sleep, and blood pressure.
- Your safety and well-being will be closely monitored throughout the study.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.
Beyond age and sex, specific health conditions or medications might mean you're not suitable for the study. For example, if you have other serious medical conditions or are taking certain medicines, the study might not be right for you.
Before you can take part, a study doctor will carefully review your medical history and current health to make sure it's safe and appropriate for you to join.
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.
- Are you 18 years old or older?
- Do you experience heart-related symptoms for which your doctor hasn't found a specific physical cause?
- Are you able to attend regular clinic visits?
- Are you willing to take a study medication, which could be an active drug or a dummy pill?
What does participation involve?
If you decide to take part, you'll be assigned either Cardiodoron or a dummy pill (placebo) — you won't know which one you're getting. You would take this medication as instructed by the study team. Over the course of the study, you'll have several visits to the study clinic. During these visits, the study team will: take measurements like your blood pressure, ask you questions about your symptoms and how you're feeling (using questionnaires), and take blood samples to check your general health.
There will be appointments at the beginning (baseline), during the treatment period (V2, V3), and at the end of the treatment (V4). These visits help us track any changes in your symptoms, sleep, quality of life, and blood pressure. You will be asked about your satisfaction with the treatment and any side effects you might experience. The total duration of your involvement in the study, including all visits and follow-ups, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is a 'dummy pill' or 'placebo'?
A dummy pill (placebo) looks exactly like the study medicine but contains no active ingredients. It helps us compare and see if the real medicine has a genuine effect.
What are 'functional cardiovascular disorders'?
These are heart-related symptoms like a racing heart or chest discomfort, where doctors can't find a clear physical problem with your heart.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know if you're getting Cardiodoron or the dummy pill. This helps ensure the study results are fair and unbiased.
How long will I be in the study?
The study team will provide you with the exact duration of your participation, including all visits and follow-up appointments.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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