Phase 3 Heart Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 20 or older (people aged 90 or older may need to complete a short memory/thinking check to confirm a minimum score)
• People who have been admitted to hospital with acute heart failure and are being treated with diuretic medication given through a vein (IV), and who have shortness of breath at rest or with very little activity, plus at least two of the following signs: swollen neck veins, crackling sounds in the lungs, swelling in the lower legs, or fluid in the lungs seen on a chest X-ray
• People whose blood test results show elevated heart failure markers (specific blood level thresholds apply depending on heart rhythm at the time of admission, and whether a certain type of heart medication is already being taken — confirm exact values with the trial site)
• People who meet at least one of these additional conditions: reduced kidney function based on a specific blood test; already taking a certain daily dose of water tablets (diuretics) before being admitted to hospital; or producing a low amount of urine (less than 300 mL) in the two hours after receiving an IV diuretic dose in hospital
• People who have given written consent to take part in the study

Who may not be able to join:

• People with severely reduced kidney function below a certain level at the time of admission (confirm threshold with trial site)
• People who have been taking a medication called an SGLT2 inhibitor in the three months before being admitted to hospital
• People with Type 1 diabetes
• People with a systolic blood pressure below 90 mmHg (the top number in a blood pressure reading)
• People expected to need certain additional fluid-removing or heart medications (thiazide, tolvaptan, or carperitide) within 48 hours of the study drug being given
• People whose heart failure admission is mainly caused by something other than fluid build-up — for example, a fast or slow heart rhythm problem, an infection, severe anaemia, or a flare-up of a chronic lung condition
• People whose current hospital admission is mainly due to a heart attack, a blood clot in the lungs, or a stroke
• People considered to be at risk of a serious blood sugar emergency (such as diabetic ketoacidosis or extremely high blood sugar)
• People currently on dialysis (including peritoneal dialysis) or for whom dialysis is planned during the hospital stay
• People who are pregnant or breastfeeding
• People who have had heart surgery, a heart procedure, or a device implanted (such as a defibrillator or heart pump) within the past 30 days
• People diagnosed with a heart attack, stroke, or mini-stroke (TIA) within the past 90 days
• People who have had a blackout caused by a dangerous heart rhythm within the past 90 days
• People who have had a heart transplant or are on a transplant waiting list with a transplant expected soon; people with an implanted heart pump or for whom one is planned; or people expected to move to palliative care
• People who are on a breathing machine (ventilator) at the time of screening, or for whom one is expected to be needed within 48 hours of the study drug being given
• People with severe heart valve disease that is expected to need surgery or a catheter-based procedure (with some exceptions — confirm with trial site)
• People diagnosed with certain specific types of heart muscle disease, including conditions such as amyloidosis, sarcoidosis, Fabry disease, or muscular dystrophy affecting the heart, as well as certain other specific heart conditions (confirm full list with trial site)
• People diagnosed with a type of heart failure related to pregnancy (peripartum cardiomyopathy) within the past 6 months
• People with active inflammation of the heart (myocarditis)
• People with an uncontrolled thyroid condition
• People with a sudden structural problem with the heart (such as a ruptured heart valve structure)
• People with a slow heart rate causing symptoms, or a complete blockage of the heart's electrical signals, who are being treated with or are expected to need a temporary pacemaker (people who already have a permanent pacemaker are not excluded)
• People with serious liver disease or liver scarring (cirrhosis) with signs of complications
• People with at least mild alcohol use disorder as defined by standard medical criteria
• People with an active cancer diagnosis or suspected active cancer within the past 2 years
• People with another serious illness (separate from heart failure) where life expectancy is estimated at one year or less
• People who have taken part in another clinical drug trial within 30 days before this hospital admission
• People who are expected to need to fast at the time of screening
• People considered unsuitable for any other safety or health reason, as determined by the trial investigators

Important: Always verify eligibility with the trial site directly before applying.