Dapagliflozin on Volume Vascular Outcomes.

Korábbi kezelés

• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;
• Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor;
• Participation in another study with investigational drug within the 30 days preceding and during the present study;
• 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;
• 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 \[11\];
• Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or implantation expected after randomization;
• Known or suspected non-compliance, drug or alcohol abuse;

Más betegség

• Type 1 diabetes mellitus;
• HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic obstructive cardiomyopathy or uncorrected primary valvular disease;
• Symptomatic bradycardia or second or third degree heart block without a pacemaker;
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant;
• Patients with recurrent mycotic genital infections;

Laborértékek

• Severe (eGFR \<20 mL/min/1.73 m2 by CKD-EPI), unstable or rapidly progressing renal disease;

Egyéb

• Symptomatic hypotension or systolic blood pressure \<90 mmHg at 2 out of 3 measurements either at visit 1 or visit 2;
• Women who are pregnant or breast feeding;
• Intention to become pregnant during the course of the study;
• Patients with severely restricted liver function;

• Male or female, age of 18 or older;
• Patients with documented diagnosis of chronic or de novo heart failure (NYHA II-IV) and clinically stabilized (considered for hospital discharge) after hospitalization/ ambulatory care because of an acute decompensated (congestive) heart failure (ADHF) event;
• eGFR ≥ 30 mL/min/1.73 m2 (CKD-EPI formula) at enrolment;
• Provision of signed informed consent prior to any study specific procedure;