The study aims to investigate the efficacy and safety of the early initiation of canagliflozin treatment in hospitalized heart failure patients with volume overload (warm-wet) who require the use of I.V loop diuretic during the hospitalization period.
The study will focus on the role of adding canagliflozin to I.V loop diuretic therapy early in unstable hospitalized acute heart failure patients regardless of diabetic state, patients who will be included in the study will continue on canagliflozin for 3 months after hospital discharge to evaluate the incidence of re-hospitalization, mortality rate and other benefits related to HF symptoms will be investigated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
142
Canagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state.
Empagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state.
National heart institute
Giza, Egypt
The cumulative mean of daily diuresis
which is define as total urine output in 24 hours during the hospitalization period.
Time frame: After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier
Measuring diuretic response
which is the cumulative change in weight (kg) from enrollment until discharge adjusted for cumulative diuretic dose in IV furosemide or equivalents
Time frame: Baseline to hospital discharge, an average of 5-6 days
The change in the level of NT-pro BNP
The change in the level of NT-pro BNP between the hospital admission day and the day of discharge.
Time frame: Baseline to hospital discharge, an average of 5-6 days
Presence of symptoms of congestion and dyspnea at discharge
measured via the change in visual analogue scale (VAS) dyspnea score between enrollment day and the discharge day. the score goes between 0-10 where 0 = no breathlessness to 10 = worst breathlessness possible.
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Intensive care unit (ICU) length of stay
measured as days from admission to ICU to discharge.
Time frame: Baseline to hospital discharge, an average of 5-6 days
The incidence of worsening of heart failure case
which is defined as failure of IV diuretic regimen to stabilize the patient state during hospitalization which requires the use of IV inotropic therapy
Time frame: Baseline to hospital discharge, an average of 5-6 days.
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Fractional Excretion of Sodium (FENa)-based diuretic efficiency
FENa per 40 mg of IV furosemide equivalents of loop dose using spot urine collected 24 hours after continues infusion of loop dose beginning and every day until patients discharge from hospital.
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Serum potassium
Serum potassium covariate with attention to both elevation and depression on a daily basis during hospitalization period.
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Incidence of ketoacidosis
reporting ketoacidosis
Time frame: Baseline to 90 days post discharge
Serum glucose covariate adjusted for baseline with attention to both elevation
(\> 400 mg/dL) and depression (\< 70 mg/dL).
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Incidence of symptomatic, sustained hypovolemic hypotension
systolic blood pressure \< 90 mmHg over 30 minutes requiring fluid administration
Time frame: Baseline to hospital discharge, an average of 5-6 days.
In-hospital mortality
incidence of mortality
Time frame: Baseline to hospital discharge, an average of 5-6 days.
Hospital readmission within 90 days of discharge for heart failure
Re-hospitalization within 90 days from hospital discharge
Time frame: within 90 post discharge
Incidence of mortality within 90 days from discharge due cardiovascular cause
Incidence of mortality
Time frame: within 90 post discharge
The incidence of worsening of renal function
which is defined as a decline in the e-GFR of 50% or greater from the baseline during any follow-up points
Time frame: Baseline to 90 post discharge
Any reported adverse events during follow up period.
ketoacidosis, genital mycotic infection, urinary tract infection, Fournier's gangrene, fractures, or amputation
Time frame: within 90 post discharge
The progression of heart failure severity
via measuring Kansas City Cardiomyopathy Questionnaire - Total Symptom Score (KCCQ-TSS) .all KCCQ scores are scaled from 0 to 100 and frequently summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent
Time frame: within 90 post discharge