Trial to establish whether dapagliflozin and spironolactone in patients with severe aortic stenosis undergoing aortic valve replacement result in better left ventricular mass regression, myocardial health and patient-reported outcomes than standard-of-care therapy alone

This trial is open to adults aged 18 and over who have been diagnosed with severe aortic stenosis and are on the waiting list for an aortic valve replacement, whether through surgery or a keyhole procedure (such as TAVI). Your heart must still be pumping blood reasonably well, with a pumping score of at least 40%.

You cannot take part if you already take these specific medicines, have severe kidney or liver disease, or have high levels of potassium in your blood. People who take insulin for diabetes or who have had a recent heart attack are also not able to join for safety reasons.

Because the study uses magnetic resonance imaging (MRI) scans to take detailed pictures of your heart, you must be able to safely lie flat inside an MRI scanner. Your hospital cardiology team will review your full medical history to confirm whether the study is a safe option for you.

Taking part lasts for about 12 months. A computer will randomly assign you to one of four groups: taking dapagliflozin once a day, taking spironolactone once a day, taking both tablets together, or receiving your standard care without any extra trial pills. You will have health checks at the start of the study and again after 12 months. These checks include an MRI scan of your heart, an ultrasound scan (echocardiogram), standard blood tests, a six-minute walking test, and short questionnaires about your daily life and symptoms. You will also have regular safety check-ups and blood tests during the year to check your kidneys and ensure the tablets agree with you.