Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 4

Summary: 
      We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients
      with acute decompensated heart failure owing to its diuretic effect in addition to
      improvement of blood glucose level without remarkable effect on kidney function or
      electrolytes.
    

Detailed description: 
      The study will include 100 diabetic patients type 2 patients who will be admitted to care
      unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if
      needed) and Diuretics plus conventional heart failure measures ,the other group will receive
      insulin for control of blood sugar plus diuretics and anti-failure measures.

      Inclusion Criteria:

      Diabetic patient type 2 with history of chronic heart failure(HFrEF) ,there is no specified
      inclusion criterion with respect to heart failure etiology and/or ejection fraction.

      Age more than 18 years Admission for acute decompensated heart failure The patient already on
      an oral loop diuretic for at least 1 month before admission, at a dose between 40 mg and 80
      mg daily in the case of furosemide and an equivalent dose in the case of a different loop
      diuretic (20 mg of Torsemide will be considered to be equivalent to 40 mg of furosemide.

      Exclusion Criteria:

        1. Other etiologies of fluid overload different from heart failure.

        2. Hyponatremia: Sodium level below 125mmol/l

        3. Unstable patients: acute coronary syndrome, cardiogenic shock .

        4. Patients requiring inotropic agents or renal dialysis.

        5. Pregnancy or breastfeeding period.

        6. sever hepatic disease

        7. GFR (Glomerular Filtration Rate) is less than 45 mL/min/1.73 m² .

        8. Patient with diabetic ketoacidosis or non ketotic hyperosmolar. Treatment arm.

      The patients will receive:

      Loop diuretics. Diuretics should be administered at doses sufficient to achieve optimal
      volume status and relieve congestion without inducing an excessively rapid reduction in
      intravascular volume.

      furosemide will be given I.V either by continuous infusion or blouses Antifailure treatment:
      (Angiotensin converting enzyme inhibitors or Angiotensin II Receptor Blockers, Beta
      Blockers,Mineralocorticoid Receptor Antagonists, Ivabradine, or others will be individualized
      according to the patient condition.

      Dapagliflozin:

      will be given in a dose of 10mg once daily ( GFR is more than 45 mL/min/1.73 m²) .

      In Mild or moderate hepatic disease: No dosage adjustment required In Severe hepatic disease:
      will not be used.

      Insulin. Insulin therapy should be initiated if blood glucose levels is ≥180 mg/dL (10.0
      mmol/L) after initiation of Dapagliflozin treatment. Once insulin therapy is started, a
      target glucose range of 140-180 mg/dL (7.8-10.0 mmol/L) is recommended The use of
      subcutaneous rapid- or short-acting insulin before meals or every 4-6 h will be given to
      correct hyperglycemia according to sliding scale chart.

      Control arm.

      The patients will be given Loop diuretics. Anti-failure treatment. Insulin.

      All the patients will undergo:

        1. Complete echo assessment.

        2. ECG on admission and daily.

        3. Monitoring:24 hours ECG ,Oxygen saturation and blood pressure monitoring. Complete blood
           count ,blood urea,serum creatinine,blood sugar,electrolytes ,liver function will be
           measured on admission

        4. Blood sugar ,urea,creatinine,Na, K will be measured daily along the whole days of
           admission.

      Follow up parameters

      Diuresis :24-hour diuresis will be quantified every 24 hours (during hospitalization) from
      the 1st day until last day of admission.

      diuretic response will be measured by weight loss and net fluid loss per mg . Changes in body
      weight measurements: the mean of weight lost every 24 hours and the total weight lost from
      baseline to the last day of hospitalization Renal function will be determined every 24 hours
      (during hospitalization) from the date of admission until the date of discharge.

      Renal function is assessed with the serum creatinine level. Worsening renal function is
      defined as an increase in the serum creatinine level of more than 0.3 mg/dl at any time
      during hospitalization Electrolyte levels (sodium and potassium) will be determined every 24
      hours (during hospitalization) from the date of admission until the date of discharge.

      Electrolyte levels are assessed with the serum sodium and potassium levels. Patient-reported
      dyspnea : Patient-reported dyspnea is assessed every 24 hours (during hospitalization) from
      the date of admission until the date of discharge.

      Patient-reported dyspnea will be assessed with the use five point Linker scale.
    

Intervention name(s): Dapagliflozin; insulin
Intervention type(s): Drug; Drug
Intervention description(s): Patient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome.; insulin
Other intervention name(s): SGLT-2 inhibitors
Intervention MeSH terms: Dapagliflozin; Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study will include 100 diabetic patients type 2 patients who will be admitted to care unit with decompensated heart failure.50 patient will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures ,the other group will receive insulin for control of blood sugar plus diuretics and anti-failure measures.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment