This study is open to adults with type 2 diabetes, high blood pressure, and cardiovascular disease. People can join the study if they have these conditions and do not have a history of heart failure. The purpose of this study is to find out if a medicine called vicadrostat, when taken with empagliflozin, helps reduce cardiovascular risk in people with these conditions. The study will compare this combination to a placebo version of vicadrostat with empagliflozin.
Participants are put into 2 groups randomly, which means by chance. One group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets with empagliflozin. Placebo tablets look like vicadrostat tablets but do not contain any medicine.
Participants take a tablet once per day for 2 and a half years and up to 4 years and 3 months. All participants also continue their medication for type 2 diabetes, high blood pressure, and cardiovascular disease. Participants have an equal chance of receiving the study medicine or placebo.
Participants are in the study for up to 4 years and 3 months. During this time, they visit the study site regularly. During these visits, doctors collect information about participants' health and take blood samples. The doctors document when participants experience cardiovascular events. The doctors also regularly check participants' health and take note of any unwanted effects.
At least 18 years old at time of consent
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2).
Participants with medical history of hypertension and on active pharmacological treatment
History of HF or hospitalization for HF or treatment of HF
Atrial fibrillation or Atrial flutter with a resting heart rate >110 beats per minute (bpm) documented by echocardiogram (ECG) at Visit 1 (screening)
Advanced untreated conduction disease or untreated clinically relevant ventricular arrhythmia at Visit 1 (screening)
Treatment with an Mineralocorticoid receptor antagonist (MRA)
Parallel
Vicadrostat
DrugVicadrostat
Empagliflozin
DrugEmpagliflozin
Placebo matching Vicadrostat
DrugPlacebo matching Vicadrostat
Time to first event of cardiovascular (CV) death or heart failure event (HFE)
Time to first event of cardiovascular (CV) death or hospitalisation for heart failure (HHF)
Absolute change from baseline in mean systolic blood pressure (SBP) [mmHg] at Week 24
Relative change from baseline in Urine Albumin Creatinine Ratio (UACR) [mg/g] at Week 24
Time to first occurrence of the composite outcome of kidney disease progression, HHF, CV death
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