Clinical Randomised Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation
This study is looking into a new medicine called AP31969 for people who have an irregular and often very fast heartbeat, known as atrial fibrillation (AF). The main goal is to find out how well different doses of AP31969 work at controlling the heart's rhythm and how safe it is. Some participants will receive the new medicine, while others will get a placebo – a dummy pill with no active ingredients. This helps researchers compare the effects accurately. All treatments are taken by mouth, twice a day. Taking part means having check-ups, some tests, and wearing a small heart monitor.
At a glance
What is this study about?
This study is a medical trial testing a new medication called AP31969. It's designed for people who have a common heart condition called atrial fibrillation, or AF. In AF, the heart beats irregularly and sometimes very quickly, which can cause symptoms like palpitations, breathlessness, and tiredness.
The main aim of this study is to explore how effective AP31969 is at helping to keep a regular heart rhythm. Researchers also want to make sure it's safe for people to take. To do this, some people in the study will receive different doses of AP31969, while others will be given a 'placebo' – a pill that looks the same but contains no active medicine. This comparison is very important because it helps scientists understand whether any changes seen are truly due to the medicine or something else.
This is a 'Phase 2' study, which means it builds on earlier research to further investigate the medicine's effects and safety in a larger group of people. The information gathered from this study will help decide if AP31969 could be a helpful treatment option for people with atrial fibrillation in the future.
Key takeaways
- The study tests a new medicine (AP31969) for irregular heartbeat (atrial fibrillation).
- It aims to see how well it controls heart rhythm and if it's safe.
- Participants will receive either the new medicine or a dummy pill (placebo).
- The study involves clinic visits, blood/urine tests, ECGs, and a small heart monitor.
- Participation lasts about 20 weeks in total.
- You can withdraw from the study at any time.
Who may be eligible?
To join this study, you need to be at least 18 years old and have a confirmed diagnosis of atrial fibrillation (AF) which has been documented by an ECG (heart tracing). This means you must have experienced AF episodes within the last few months, and your AF should fall within a certain range as measured during the study's screening period.
It's important that you haven't recently had certain heart events like a heart attack or stroke in the last four weeks. You also shouldn't have specific other heart problems, such as severe heart failure or certain types of heart valve disease. If you have a pacemaker that constantly paces your heart, or if you've had certain complex heart procedures in the past (other than a common one called pulmonary vein isolation), you might not be able to take part.
Finally, you must be willing to avoid other treatments for controlling your heart rhythm, such as certain medications or procedures, while you are in the study. You also need to be able to have a small heart monitoring device implanted, and you should be happy to provide written consent, showing you understand and agree to participate.
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?
- Has a doctor confirmed you have atrial fibrillation (AF)?
- Have you had AF episodes recently?
- Do you not have severe heart failure or certain other serious heart conditions?
- Are you able to have a small heart monitor implanted?
- Are you willing to avoid other rhythm control treatments during the study?
What does participation involve?
If you decide to take part in this study, you'll be involved for about 20 weeks in total. This includes an initial ‘screening’ period of up to 4 weeks to check if the study is right for you, followed by 12 weeks during which you'll take the study medication, and then a 30-day follow-up period.
You'll be randomly assigned to one of several groups. Some groups will receive different doses of the new medicine (AP31969), while one group will receive a placebo (a dummy pill with no active ingredient). All treatments are taken by mouth, twice every day.
Throughout the study, you'll have several visits to the clinic for assessments. These will include blood and urine tests, and electrocardiograms (ECGs) to check your heart's electrical activity. You will also have a small heart monitor (called an implantable loop recorder) fitted, which will continuously track your heart rhythm. This device helps the study team understand how your heart is responding to the treatment.
Potential risks and benefits
Locations (38)
- UMHAT "Sveti Georgi" EAD, Department of Invasive CardiologyVerified postcodePlovdiv, Bulgaria· Not yet recruiting
- Acibadem City Clinic, Cardiology DepartmentVerified postcodeSofia, Bulgaria· Recruiting
- MHAT National Cardiology Hospital EAD, Cardiology DepartmentVerified postcodeSofia, Bulgaria· Withdrawn
- Aleksandrovska University Hospital, Clinic of CardiologyVerified postcodeSofia, Bulgaria· Not yet recruiting
- SHATC Cardiolife, Invasive CardiologyVerified postcodeVarna, Bulgaria· Recruiting
- Medical Center Nova ClinicVerified postcodeVarna, Bulgaria· Recruiting
- University Hospital Herlev and Gentofte Department of CardiologyVerified postcodeHellerup, Denmark· Recruiting
- Viborg Hospital, Department of CardiologyVerified postcodeViborg, Denmark· Recruiting
- Sana Kliniken Oberfranken, Klinikum Coburg Kardiologie und Innere MedizinVerified postcodeCoburg, Germany· Not yet recruiting
- Universitätsklinikum Frankfurt Medizinische Klinik III - Kardiologie, Angiologie, Hämostaseologie, NephrologieVerified postcodeFrankfurt, Germany· Recruiting
- Universitaets Klinikum Hamburg-Eppendorf (UKE Hamburg), KardiologieVerified postcodeHamburg, Germany· Recruiting
- Budai Irgalmasrendi KórházVerified postcodeBudapest, Hungary· Not yet recruiting
Common questions
What is atrial fibrillation?
Atrial fibrillation is a common heart condition where the heart's upper chambers beat irregularly and often very quickly, which can make you feel breathless or have palpitations.
What is a 'placebo'?
A placebo is a 'dummy' pill that looks just like the real medicine but contains no active ingredients. It's used in studies to help researchers compare the effects of the actual medicine.
How long will I be in the study?
If you join, you'll be in the study for about 20 weeks in total, including screening, treatment, and follow-up.
Will I know if I'm getting the real medicine or the placebo?
No, in this type of study, neither you nor the study team will know whether you are receiving the active medicine or the placebo. This helps ensure the results are unbiased.
What is an implantable loop recorder?
It's a small, long-term heart monitor that's placed just under the skin. It continuously records your heart's electrical activity to help track your rhythm.
How to find out more
Birgitte Vestbjerg
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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