A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
This study is researching a new medication called sotagliflozin for people living with a heart condition called hypertrophic cardiomyopathy (HCM). HCM causes the heart muscle to become thick, making it harder for the heart to pump blood effectively, leading to symptoms like shortness of breath or chest pain. The study wants to see if sotagliflozin can reduce these symptoms and improve a person's ability to do daily activities. Participants will receive either sotagliflozin or a placebo (a dummy pill) to compare the effects. This is a Phase 3 study, meaning it's one of the final stages of testing before a new drug might become widely available.
At a glance
What is this study about?
This research is looking into a condition called hypertrophic cardiomyopathy, often shortened to HCM. This is a heart condition where the heart muscle, especially the main pumping chamber (left ventricle), becomes unusually thick. This thickening can make it harder for your heart to pump blood around your body effectively. Some people with HCM might have an "obstructive" form, where the thickened muscle blocks blood flow out of the heart, while others have a "non-obstructive" form without this blockage. Regardless of the type, HCM can lead to symptoms like feeling out of breath, chest pain, or feeling very tired.
The study is testing a new medication called sotagliflozin. Researchers want to understand if this drug can help people with HCM feel better. They'll be looking to see if it reduces symptoms and helps people go about their daily lives more easily. To get a clear answer, some participants will receive the actual drug, while others will receive a placebo – a tablet that looks the same but contains no active medicine. This allows doctors to compare the effects of the drug against what would happen without it.
By taking part, you would be contributing to important research that could potentially help many other people with HCM in the future. The study is particularly interested in how sotagliflozin affects your overall well-being and ability to carry out everyday activities.
Key takeaways
- This study is for people with hypertrophic cardiomyopathy (HCM).
- It's testing a new drug called sotagliflozin against a placebo (dummy pill).
- The main goal is to see if sotagliflozin improves HCM symptoms and quality of life.
- Participation involves taking medication and attending regular clinic visits for checks.
- You will receive close medical monitoring from specialists.
Who may be eligible?
To join this study, you would need to be at least 18 years old. You must have been diagnosed with hypertrophic cardiomyopathy (HCM), which is a condition where your heart muscle is thicker than usual. Your HCM might be causing symptoms that affect your daily life.
Specifically, for the 'obstructive' type of HCM, doctors will check if there's a certain level of blockage to blood flow from your heart. If you have the 'non-obstructive' type, they'll confirm there's no significant blockage. Your heart's pumping strength (ejection fraction) also needs to be at a certain level. If you're already taking other heart medications, these should have been at a steady dose for at least a month.
You wouldn't be able to join if you've recently taken a similar type of medication (an SGLT2 inhibitor) or had a bad reaction to one in the past. Also, if you're already taking certain other specific medications like digoxin or if you're involved in another medical study right now, you would not be eligible.
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 or older?
- Do you have a diagnosis of hypertrophic cardiomyopathy (HCM)?
- Are your HCM symptoms currently affecting your daily life?
- Are you currently NOT taking certain other specific heart medications (like digoxin)?
- Have you NOT taken a similar type of medicine called an SGLT2 inhibitor recently?
- Are you currently NOT participating in another medical study?
What does participation involve?
Taking part in this study would involve regular visits to the clinic over a period. You would be given study medication – either sotagliflozin or a placebo – to take regularly. Throughout the study, doctors and nurses would perform various assessments to monitor your health, how your heart is working, and how your symptoms are changing. These might include heart scans, blood tests, and questionnaires about how you're feeling and your daily activities. There will be initial screening appointments to see if you're a good fit, treatment periods where you take the medication, and follow-up appointments after the main treatment phase. The full duration of your involvement, including all visits and follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (108)
- Lexicon Investigational Site (4041)Verified postcodePhoenix, United States· Recruiting
- Lexicon Investigational Site (4037)Verified postcodeScottsdale, United States· Recruiting
- Lexicon Investigational Site (4012)Verified postcodeLos Angeles, United States· Recruiting
- Lexicon Investigational Site (4035)Verified postcodePomona, United States· Recruiting
- Lexicon Investigational Site (4044)Verified postcodeSan Francisco, United States· Recruiting
- Lexicon Investigational Site (4046)Verified postcodeJacksonville, United States· Recruiting
- Lexicon Investigational Site (4034)Verified postcodeOrlando, United States· Recruiting
- Lexicon Investigational Site (4018)Verified postcodeAtlanta, United States· Recruiting
- Lexicon Investigational Site (4033)Verified postcodeEvanston, United States· Recruiting
- Lexicon Investigational Site (4036)Verified postcodeMerrillville, United States· Recruiting
- Lexicon Investigational Site (4021)Verified postcodeBaltimore, United States· Recruiting
- Lexicon Investigational Site (4016)Verified postcodeBoston, United States· Recruiting
Common questions
What is hypertrophic cardiomyopathy (HCM)?
It's a heart condition where the heart muscle, especially the main pumping chamber, becomes thicker than normal, making it harder for the heart to pump blood effectively.
What is sotagliflozin?
Sotagliflozin is the name of the new medication being tested in this study to see if it can help people with HCM.
What is a 'placebo'?
A placebo is a 'dummy' tablet or treatment that looks exactly like the study medication but doesn't contain any active drug. It helps compare the real drug's effects.
Will I know if I'm getting the real drug or the placebo?
No, this is usually a 'blinded' study, meaning neither you nor your doctor will know whether you are receiving sotagliflozin or the placebo until after the study is complete, to ensure fair results.
Can I stop participating in the study if I change my mind?
Yes, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Tracy Newbold
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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