Impact on Atrial Remodeling of Dapaglifozin in Patients With Heart Failure . (MODA)

This is an interventional treatment trial for Heart Failure Read More

Inclusion Criteria:

• Age > 18 years

  • Prior diagnosis of HF, with at least one hospitalization for HF at any time.
• NYHA class I-IV.
• LVEF available (echocardiogram or cardiac MRI) within the last 12 months prior to enrolment.
• Treatment according with contemporary guidelines recommendations and with stable doses of oral loop diuretics for at least 4 weeks
• NT-proBNP >600 pg/ml at screening (≥400 pg/ml if hospitalized for HF within the previous 12 months; ≥900 pg/ml If concomitant AF at
• Screening irrespective of time to last HF hospitalization).

Exclusion Criteria:

• Dapagliflozin or other SGLT2i at any time in prior 6 months.
• Type 1 diabetes mellitus (T1D)
• Estimated glomerular filtration rate < 30 ml/min/1.73 m2 as measured by the simplified Modification of Diet in Renal Disease (MDRD) formula at screening.
• Symptomatic hypotension or systolic blood pressure (SBP) <95 mmHg on 2 consecutive measurements at screening.
• Uncontrolled hypertension, defined as SBP >160 mmHg.
• Current acute decompensated HF or hospitalization due to decompensated HF within 4 weeks prior to enrolment
• The use of outpatient or inpatient i.v. diuretic therapy within 4 weeks prior to baseline.
• Subjects who are currently receiving or have received inotropic agents within 12 weeks prior to baseline.
• Myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment
• Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrolment or planned to undergo any of these operations after inclusion
• Implantation of a cardiac resynchronization therapy (CRT) within 12 weeks prior to enrolment or intent to implant a CRT device
• Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion
• 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
• History of allergic reactions or intolerance to dapagliflozin, or other iSGLT2, or any other compound
• History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within one year.
• Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of screening)
• Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator or women who have a positive pregnancy test at enrollment or randomization or women who are breast-feeding
• Participation in another clinical trial during the last month prior to enrolment
• Inability of the patient, in the opinion of the investigator, to understand and/or comply with study medications, procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study
• Any concomitant disease limiting life expectancy in the following year (other than heart failure)
• No possibility to give informed consent.