SPironolactONe for the maintenance of Sinus Rhythm in hypertensive patients with atrial fibrillation and preserved left ventricular ejection fraction: a Prospective Randomized Open Blinded End-point (PROBE) multicenter study (SPONSoR study).
The SPonsor study is investigating if a common blood pressure medication, spironolactone, can help people with high blood pressure who also experience an irregular heartbeat, known as atrial fibrillation (AF). The main goal is to see if spironolactone can help maintain a regular heart rhythm and prevent AF from returning. Researchers will follow participants for 12 months to see how often AF episodes happen, how long they last, and if they cause symptoms. They'll also look at overall heart health and any side effects of the medication. This is a Phase III study, meaning it's a large trial to confirm the treatment's effectiveness and safety, and could lead to new ways to help manage AF.
At a glance
What is this study about?
This study, called the SPONSoR study, is looking into whether a medication named spironolactone can help people who have high blood pressure and a type of irregular heartbeat called atrial fibrillation (AF). In atrial fibrillation, the two upper chambers of your heart beat irregularly, which can sometimes lead to uncomfortable symptoms like palpitations, tiredness, or shortness of breath. This study focuses on people whose hearts are otherwise pumping well.
The main aim of the study is to see if spironolactone can help keep your heart in a regular rhythm and prevent these atrial fibrillation episodes from coming back. The researchers will be carefully monitoring participants for 12 months to understand if spironolactone can reduce how often AF occurs, and if it does, how long those episodes last. They'll also be tracking other important health measures like blood pressure, and looking out for any serious heart-related problems or side effects.
This is a 'Phase III' study, which means it’s a large and important step in understanding this treatment. If successful, the results could help doctors and patients in the future to better manage atrial fibrillation in people with high blood pressure. It's about finding new and effective ways to improve heart health and quality of life.
Key takeaways
- This study investigates if spironolactone can help maintain a regular heart rhythm in people with high blood pressure and atrial fibrillation.
- It lasts for 12 months and involves taking a daily tablet and regular health checks.
- A key focus is to prevent atrial fibrillation episodes from returning.
- Participants will have their heart rhythm monitored, including using a special wearable watch.
- The study aims to improve understanding of how to manage atrial fibrillation and high blood pressure.
- You can stop participating at any time if you change your mind.
Who may be eligible?
To join this study, participants must be at least 18 years old – there's no upper age limit. The study is open to both men and women.
Key to eligibility is having high blood pressure and a diagnosis of atrial fibrillation. It's also important that your heart's main pumping chamber (the left ventricle) is still working well.
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?
- Have you been diagnosed with high blood pressure?
- Do you have atrial fibrillation?
- Has your doctor told you that your heart's main pumping chamber (left ventricle) is working well?
What does participation involve?
If you decide to take part in this study, you will be given the study medication, spironolactone (25 mg, once a day), which is a tablet you can split if needed. The study will last for 12 months from the day you officially start. During this time, you'll have regular check-ups where your blood pressure will be measured. You'll also likely wear a special watch (ScanWatch 42mm®) that helps monitor your heart rhythm for atrial fibrillation.
Researchers will be looking to see if your atrial fibrillation comes back and, if so, how often and for how long. You'll also have blood tests to check things like your potassium levels and kidney function, as these can sometimes be affected by spironolactone. Throughout the study, the research team will explain everything clearly and be there to answer your questions.
Potential risks and benefits
Locations (1)
- —UnverifiedFrance
Common questions
What is atrial fibrillation?
Atrial fibrillation (AF) is an irregular and often very rapid heart rate that can cause symptoms like palpitations or tiredness. It means the upper chambers of your heart aren't beating properly.
What is spironolactone?
Spironolactone is a medicine often used to treat high blood pressure, fluid retention, and heart failure. It works by helping your body get rid of excess water and salt.
How long will I be in the study?
If you join the study, you'll be involved for 12 months after you're assigned to a treatment group.
Will I know if I'm taking the study drug?
This study is 'open', meaning both you and the research team will know you are taking spironolactone. However, the exact results will be analysed separately by people who don't know who received what treatment.
What will happen if my atrial fibrillation comes back?
The study team will monitor for any return of your atrial fibrillation through ECGs and a wearable device. Your medical team will discuss any recurrences with you and what that means for your care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.