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Canagliflozin in Patients With Acute Decompansted Heart Failure

Phase 3
Completed
Conditions
Chronic Heart Failure
Acute Heart Failure
Diabetes Mellitus
Interventions
Registration Number
NCT05364190
Lead Sponsor
October 6 University
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
142
Inclusion Criteria

Randomized within 24 of presentation during hospital admission for hypervolemic ADHF with evidence of congestion defined by the presence of any of the following signs or symptoms:

Peripheral edema Ascites Jugular venous pressure > 10 mmHg Orthopnea Paroxysmal nocturnal dyspnea 2.5 kg weight gain Signs of congestion on chest X-ray or lung ultrasound If pulmonary artery catheterization is available pulmonary capillary wedge pressure > 19 mmHg plus a systemic physical examination finding of hypervolemia.

Planned use of intravenous (IV) loop diuretic therapy during the current hospitalization Estimated glomerular filtration rate (e-GFR) > 30 mL/min/1.73 m2 based on the Modification of Diet in Renal Disease (MDRD) equation.

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Exclusion Criteria

Type 1 diabetes Serum glucose < 80 mg/dL Systolic blood pressure < 90 mmHg Requirement of IV inotropic therapy History of hypersensitivity to any SGLT-2 inhibitors Already receiving therapy with an SGLT2 inhibitor Women who are pregnant or breastfeeding Severe anemia (Hemoglobin < 7.5 g/dL)(24) Severe uncorrected aortic or mitral stenosis Inability to perform standing weights or measure urine output accurately Signs of ketoacidosis and/or hyperosmolar hyperglycaemic syndrome (pH >7.3 and glucose > 250 mg/dL and HCO3 > 18 mmol/L) in diabetic patients at the time of inclusion to the study.

The use of other diuretic therapies including; ≥100 mg/day spironolactone doses, ≥ 100 mg/day eplerenone, metolazone, hydrochlorothiazide, or other thiazides, systemic acetazolamide for the indication of diuretics, triamterene, or amiloride therapy.

The use of other medications possessing natriuretic effect as nesiritide, or arginine vasopressin antagonists.

Diffuse anasarca with 4+ edema and projected hypervolemia exceeding 18 kg. Severe hepatic impairment (Child-Pugh class C). Patients on hemodialysis Acute myocardial infarction with symptoms of acute ischemia or changes on electrocardiogram

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group A(Intervention group)Canagliflozinpatients will receive 100 mg canagliflozin initiated within 24 hours from patients hospital admission due to signs of hypervolemic state. All patients also will be prescribed the conventional diuretic therapy and other medications such as angiotensin-converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), beta-blockers, angiotensin receptor-neprilysin inhibitor (ARNI) and mineralocorticoid receptor antagonists (MRAs). Canagliflozin will be continued for 90 days after hospital discharge
Group BEmpagliflozinpatients will receive 10 mg Empagliflozin initiated within 24 hours from patients hospital admission due to signs of a hypervolemic state.All patients also will be prescribed conventional diuretic therapy and other medications including ACEIs, ARBs, beta-blockers, ARNI, and MRAs.Empagliflozin will be continued for 90 days after hospital discharge
Primary Outcome Measures
NameTimeMethod
The cumulative mean of daily diuresisAfter (day1)24 hours from hospital admission and until Day 5 or discharge if earlier

which is define as total urine output in 24 hours during the hospitalization period.

Secondary Outcome Measures
NameTimeMethod
Incidence of mortality within 90 days from discharge due cardiovascular causewithin 90 post discharge

Incidence of mortality

Incidence of ketoacidosisBaseline to 90 days post discharge

reporting ketoacidosis

Serum potassiumBaseline to hospital discharge, an average of 5-6 days.

Serum potassium covariate with attention to both elevation and depression on a daily basis during hospitalization period.

Measuring diuretic responseBaseline to hospital discharge, an average of 5-6 days

which is the cumulative change in weight (kg) from enrollment until discharge adjusted for cumulative diuretic dose in IV furosemide or equivalents

Presence of symptoms of congestion and dyspnea at dischargeBaseline to hospital discharge, an average of 5-6 days.

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.

The incidence of worsening of heart failure caseBaseline to hospital discharge, an average of 5-6 days.

which is defined as failure of IV diuretic regimen to stabilize the patient state during hospitalization which requires the use of IV inotropic therapy

Fractional Excretion of Sodium (FENa)-based diuretic efficiencyBaseline to hospital discharge, an average of 5-6 days.

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.

Serum glucose covariate adjusted for baseline with attention to both elevationBaseline to hospital discharge, an average of 5-6 days.

(\> 400 mg/dL) and depression (\< 70 mg/dL).

The change in the level of NT-pro BNPBaseline to hospital discharge, an average of 5-6 days

The change in the level of NT-pro BNP between the hospital admission day and the day of discharge.

Intensive care unit (ICU) length of stayBaseline to hospital discharge, an average of 5-6 days

measured as days from admission to ICU to discharge.

Incidence of symptomatic, sustained hypovolemic hypotensionBaseline to hospital discharge, an average of 5-6 days.

systolic blood pressure \< 90 mmHg over 30 minutes requiring fluid administration

In-hospital mortalityBaseline to hospital discharge, an average of 5-6 days.

incidence of mortality

Hospital readmission within 90 days of discharge for heart failurewithin 90 post discharge

Re-hospitalization within 90 days from hospital discharge

The progression of heart failure severitywithin 90 post discharge

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

The incidence of worsening of renal functionBaseline to 90 post discharge

which is defined as a decline in the e-GFR of 50% or greater from the baseline during any follow-up points

Any reported adverse events during follow up period.within 90 post discharge

ketoacidosis, genital mycotic infection, urinary tract infection, Fournier's gangrene, fractures, or amputation

Trial Locations

Locations (1)

National heart institute

🇪🇬

Giza, Egypt

National heart institute
🇪🇬Giza, Egypt
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