Phase 3 Chronic Kidney 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 18 years or older.
• People who have chronic coronary syndrome (a long-term heart condition affecting blood supply) and are scheduled for planned, non-emergency heart bypass surgery (CABG) using a heart-lung machine, either on its own or combined with aortic valve replacement, mitral valve surgery, and/or aortic root surgery.
• People who are able to give written consent to participate.

Who may not be able to join:

• People who have taken a type of diabetes medication called an SGLT2 inhibitor in the 8 weeks before joining, or who are planning to take one.
• People who are unable to tolerate or are allergic to the study drug dapagliflozin, or have another medical reason not to take it.
• People who have Type 1 diabetes.
• People with low blood pressure symptoms or a systolic blood pressure reading below 95 mmHg on two out of three measurements at enrolment.
• People currently experiencing a severe worsening of heart failure, or who were hospitalised for severely worsened heart failure within the 4 weeks before joining.
• People whose heart failure is caused by certain specific heart conditions, including restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, or hypertrophic cardiomyopathy (confirm with trial site if unsure which category applies).
• People who have had a heart rhythm device (cardiac resynchronisation device) implanted, or are planning to have one implanted, within 12 weeks before joining.
• People who have had a stroke or a mini-stroke (transient ischemic attack) within the 12 weeks before joining.
• People who have a dangerously slow heart rate or certain types of heart conduction problems (second or third-degree atrioventricular block) and do not have a pacemaker.
• People with a serious illness, such as cancer, where life expectancy is estimated to be less than 2 years, based on the doctor's assessment.
• People with significant liver problems, based on blood test results at the time of joining.
• People with severe, unstable, or rapidly worsening kidney disease at the time of joining.
• People whose bypass surgery is planned to take place within one week of joining.
• People requiring emergency surgery with an unstable circulation.
• People who have a previous history of atrial fibrillation (an irregular heart rhythm condition).
• Women who are able to become pregnant, unless they are willing to use a highly effective form of contraception throughout the trial and for 4 weeks after it ends, as judged by the investigator.
• Women who have a positive pregnancy test at the time of joining or being assigned to a treatment group.
• Women who are currently breastfeeding.
• People who have taken part in another clinical trial using an investigational medicine within 30 days before being assigned to a treatment group.
• People who have previously taken part in this specific trial (called the STENOTYPE trial).
• People who have difficulty understanding what participation in the trial involves, due to language barriers, cognitive difficulties, or unwillingness, in the opinion of the investigator.

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