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This study examined the metabolic effects of the drug Empagliflozin, compared with placebo, in patients at high risk of developing heart failure. It enrolled people aged 60-84 with a body mass index above 28 who had at least one risk factor such as hypertension, ischemic heart disease, or chronic kidney disease. It was a Phase 2 study and is completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Body mass index \>28kg/m2 * Age 60-84 years * Established risk factor for developing heart failure, defined as at least one of the following: * hypertension * ischemic heart disease * stroke/transient cerebral ischemia * chronic kidney disease (eGFR 30-45ml/min/1.73m2) Exclusion Criteria: * Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment) * Heart failure with reduced ejection fraction (LVEF \<40%) * Inability to perform exercise test * Dementia * Severe non-compliance * Substance abuse * Severe chronic obstructive pulmonary disease (FEV1\<50% expected value) * Permanent atrial fibrillation * GFR \<30 ml/min/1,73m2 * Severe peripheral artery disease * Cancer treatment within one year beside prostate cancer and basal cell carcinoma * Severe aortic or mitral valve disease * Pregnancy or breastfeeding * Acute hospital admission within 30 days * Participation in other pharmacological study