Effect of the Use of Dapagliflozin in Patients With Refractory Heart Failure

Korábbi kezelés

• Patients without indication of beginning treatment with Dapagliflozin according to the Data Sheets and Consumer Medicine Information.
• Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 1 month prior to enrollment.
• Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement) within 1 month prior to enrollment or planned to undergo any of these operations after randomization.
• Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 1 month prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
• Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
• Residual urine volume less than 500ml daily or reduction in urinary output by 24 hours (< 30% compared to previous routine control) within 30 days prior to consent
• Participation in another clinical study with an investigational product during the last 3 months.
• Previous enrolment in the present study.

Más betegség

• Malignancy (with active treatment) or other life-threatening disease
• Type 1 Diabetes
• Patients with a known hypersensitivity to Dapagliflozin or any of the excipients of the product.

Egyéb

• Limited life expectancy (less than 1 year) based on investigator's clinical judgement.
• Patients in whom proper study compliance cannot be guaranteed
• Rejection or revocation of informed consent
• Pregnant or breast-feeding women
• Patients with amputated limbs will be excluded of bioimpedance analysis.
• Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
• Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.

• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Provision of informed consent form prior to any study specific procedures, sampling and analysis.
• Individuals must be ≥ 18 years of age at the time of signing the informed consent
• Individuals must have a confirmed diagnosis of Heart Failure (HF) according to clinical practice guidelines NYHA functional class I-III (with HFrEF or HFpEF).
• In treatment with Peritoneal Dialysis technique
• Chronic Kidney Disease (eGFR < 60 ml/min/m2 CKD-EPI formula)
• PD vintage of more than 30 days
• On stable doses of furosemide, or alternative loop diuretic for 14 days
• On stable HF therapy for at least 1 month prior to consent
• No hospitalizations for HF for at least 1 month prior to consent