Sacubitril/valsartan is an established medication for heart failure. However, data still lags in its use in heart failure patients with chronic kidney disease. Sacubitril/valsartan is manufacturer-labeled for use in patients with eGFR \< 30 ml/min/1.73 m2 at an initial dose of 24/26mg twice daily. However, to the best of our knowledge, the concept of sacubitril/valsartan or ACEi in patients with chronic kidney disease \& presenting with decompensated heart failure has not yet been explored fully.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
515
Patients will receive sacubitril/valsartan at an initial dose of 24/26 mg Bid.
Patients will receive ramipril at an initial dose of 2.5 mg Bid.
Cairo University Hospitals
Cairo, Egypt
National Heart Institute
Cairo, Egypt
Difference in mean eGFR (mL/min/1.73m2) between both groups at 12 weeks post-randomization.
Time frame: 12 weeks
Number of patients in each group who develop worsening renal function throughout the study period.
Defined as a 50% increase in the serum creatinine level (mg/dL) from baseline and/or a drop in eGFR by more than 25 ml/min/1.73m2.
Time frame: 12 weeks
Number of events in each group for hyperkalemia throughout the study period.
Defined as a rise in serum potassium level to ≥ 5.5 mEq/L .
Time frame: 12 weeks
Number of events in each group for symptomatic hypotension throughout the study period.
Defined as the subjective sense of dizziness or lightheadedness, blurred, or fading of vision, fainting, fatigue, difficulty concentrating and/or nausea in the presence of a BP of 90/60mmHg or lower.
Time frame: 12 weeks
Number of events in each group for angioedema throughout the study period.
Defined as a swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosal tissues.
Time frame: 12 weeks
Difference between uACR levels (gm/mg) in each group at 12 weeks post-randomization.
Time frame: 12 weeks
Difference between NT-proBNP levels (pg/mL) in each group at 12 weeks post-randomization
Time frame: 12 weeks
Difference between LVEF (%) of each group at 12 weeks post-randomization
Time frame: 12 weeks
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