The use of empagliflozin in patients with hypertrophic cardiomyopathy
Hypertrophic cardiomyopathy is a condition where the heart muscle becomes thicker than normal, making it harder for the heart to pump blood around the body. This can cause breathlessness, tiredness, and chest discomfort during everyday activities. This Phase 3 clinical trial is testing a medicine called empagliflozin (brand name Jardiance). While already approved for diabetes and certain types of heart failure, doctors want to find out if it can also help people with hypertrophic cardiomyopathy. Participants will take either a 10 mg empagliflozin tablet or a dummy tablet (placebo) once a day for 12 months. Researchers will measure how much oxygen participants' bodies can use during exercise and check improvements in their day-to-day symptoms through a standard quality-of-life questionnaire.
At a glance
What is this study about?
Hypertrophic cardiomyopathy is an inherited condition that causes the walls of the heart muscle to thicken. Over time, this thickening makes the heart stiffer, so it cannot fill with or pump blood as easily. People living with this condition often experience shortness of breath, fatigue, chest pain, and difficulty keeping up with regular physical activities.
Empagliflozin is a medicine that helps the body remove extra sugar and fluid through the urine. It is already widely used to treat type 2 diabetes and some forms of heart failure because it takes pressure off the heart. In this trial, scientists want to find out if empagliflozin can also protect the heart and improve fitness in people whose heart muscle is thickened.
To find out if the drug works, participants will be randomly placed into one of two groups. One group will take the real empagliflozin tablet once a day, and the other will take an inactive dummy tablet (placebo). Comparing both groups helps doctors see if any improvements in stamina and daily well-being are genuinely caused by the medicine.
If the results are positive, this trial could provide doctors with an effective new treatment option to help people with hypertrophic cardiomyopathy live more active, comfortable lives.
Key takeaways
- Tests whether the tablet empagliflozin can improve exercise capacity in hypertrophic cardiomyopathy.
- Compares the daily tablet against an inactive dummy pill (placebo) over 12 months.
- Open to adults aged 18 and over with confirmed hypertrophic cardiomyopathy.
- Main assessments include fitness tests and quality-of-life questionnaires.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with hypertrophic cardiomyopathy. Both men and women are welcome to take part.
Because this study looks closely at physical fitness, participants should generally be able to undertake basic exercise tests, such as riding a stationary exercise bike or walking on a treadmill.
People with certain other severe medical problems, or those who are already taking similar medications, may not be able to join. The trial doctor will review your full medical history and perform health checks to make sure taking part is safe for you.
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.
- I am 18 years of age or older.
- I have been diagnosed by a doctor with hypertrophic cardiomyopathy.
- I am able and willing to perform walking or cycling exercise tests.
- I can commit to taking a daily tablet and attending clinic visits for 12 months.
What does participation involve?
Taking part in this study lasts for about 12 months. You will be assigned by chance (like flipping a coin) to take either one empagliflozin tablet (10 mg) or one identical-looking dummy tablet once daily. Neither you nor your study doctor will know which one you are taking.
Over the course of the year, you will visit the clinic several times for health check-ups. These visits will include physical examinations, blood tests, and heart monitoring. You will also take an exercise fitness test (often on a stationary bike) to measure how well your body uses oxygen, and you will complete questionnaires asking about your daily symptoms and energy levels.
After 12 months of treatment, final assessments will be completed to measure any changes in your fitness and overall quality of life.
Potential risks and benefits
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Common questions
What is empagliflozin?
Empagliflozin is an approved medication commonly used to treat type 2 diabetes and heart failure. It works by helping the kidneys remove excess sugar and salt through your urine, which can ease strain on the heart.
What is a placebo?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. It allows researchers to see if the actual drug produces real health improvements beyond the psychological effect of taking a pill.
Will I have to pay to take part?
No. Clinical trials in the UK provide the study medication, tests, and medical visits free of charge. Some trials also help cover travel expenses to and from the hospital.
What is the exercise test involved?
The test measures your 'VO2 max', which is the maximum amount of oxygen your body can use while exercising. You will usually pedal an exercise bike or walk on a treadmill while wearing a mask that measures your breathing.
Can I leave the study if I change my mind?
Yes. You have the right to withdraw from the trial at any point, for any reason, and your normal NHS care and relationship with your doctors will stay the same.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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