Dapagliflozin on Volume Vascular Outcomes.

Exclusion Criteria

• •1. Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
• •2. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor;
• •3. Participation in another study with investigational drug within the 30 days preceding and during the present study;
• •4. Type 1 diabetes mellitus;
• •5. Symptomatic hypotension or systolic blood pressure \<90 mmHg at 2 out of 3 measurements either at visit 1 or visit 2;
• •6. Coronary revascularization (percutaneous coronary intervention because of STEMI or coronary artery bypass grafting) or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after randomization;
• •7. Implantation of a CRT device within 12 weeks prior to enrolment or intent to implant a CRT device during 12 weeks of study observation period if indicated according to the actual guidelines \[11\];
• •8. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization;
• •9. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy or uncorrected primary valvular disease;
• •10. Symptomatic bradycardia or second or third degree heart block without a pacemaker;
• •11. Severe (eGFR \<20 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease;
• •12. Women who are pregnant or breast feeding;
• •13. Intention to become pregnant during the course of the study;
• •14. Known or suspected non-compliance, drug or alcohol abuse;
• •15. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;
• •16. Patients with severely restricted liver function;
• •17. Patients with recurrent mycotic genital infections;