HF Prevalence and Evolution of HF in DM II Patients at High Risk

Korábbi kezelés

• Treatment with SGLT2 inhibitor at the time of providing informed consent.
• History of HF (defined as current or previous receipt of treatment prescribed for the management of HF, and/or hospitalization for HF at any time in the past).
• History of any malignancy within the 5-year period prior to enrollment (with the exception of successfully treated non-melanoma skin cancers).
• Patients who are currently receiving treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) prior to enrollment.

Más betegség

• Patients with limitations in their functional capacity that, as per the physician's judgment, are attributed to non-cardiac medical reason or condition (such as lung disease, musculoskeletal disorders, infection, endocrine disorders etc.).
• Chronic cystitis and/or recurrent genital or urinary tract infections (3 or more in the last year).
• Acute kidney injury or rapidly progressing renal disease.
• Patients with lifetime expectancy less than 2 years due to any non-cardiovascular cause or with any non-cardiac condition which, in the judgment of the Investigator, may render the patient unable to complete the study.

Laborértékek

• Severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73m2 using the CKD-EPI equation).
• HbA1c level ≥12%.
• Aspartate or alanine aminotransferase >3 x upper limit of normal (ULN) or total bilirubin >2.5xULN.

Egyéb

• Diagnosis of type 1 DM.
• Hematuria (confirmed by microscopic evaluation) with no explanation as judged by the study physician.
• Pregnant or breastfeeding patient.
• Patients who have already been enrolled in this study or in a study of the same design which the physician has good reasons to believe that it is this study (to exclude enrollment of the same patient by two different sites).

• Female or male outpatients aged 40 to 80 years (inclusive) at the time of providing informed consent.
• T2DM diagnosis within 10 years prior to enrollment.
• Patients must have a high or very high cardiovascular risk (as outlined in 2019 ESC Guidelines on diabetes, pre-diabetes and CV diseases).
  • Note: Very high CV risk is defined as having either established CV disease, or other target organ damage (proteinuria, LVH, or retinopathy), or at least three major risk factors. High CV risk is defined as age ≥ 50 years and presence of at least one additional major risk factor. Major risk factors include age ≥ 50 years, hypertension, dyslipidemia, smoking, and obesity.
• Patients must have available medical records for data abstraction to meet the objectives of the study.
• Written signed and dated informed consent.