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Completed

NCT Number: NCT05364190

Canagliflozin in Patients With Acute Decompansted Heart Failure

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National heart institute

Giza, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Canagliflozin

Drug

Canagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state.

Empagliflozin

Drug

Empagliflozin will be used in hospitalized heart failure patients regardless of their diabetic state.

Primary outcomes

  1. The cumulative mean of daily diuresis

    Time frame: After (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 outcomes

  1. Measuring diuretic response

    Time frame: Baseline 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

  2. The change in the level of NT-pro BNP

    Time frame: Baseline 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.

  3. Presence of symptoms of congestion and dyspnea at discharge

    Time frame: Baseline 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.

  4. Intensive care unit (ICU) length of stay

    Time frame: Baseline to hospital discharge, an average of 5-6 days

    measured as days from admission to ICU to discharge.

  5. The incidence of worsening of heart failure case

    Time frame: Baseline 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

  6. Fractional Excretion of Sodium (FENa)-based diuretic efficiency

    Time frame: Baseline 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.

  7. Serum potassium

    Time frame: Baseline 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.

  8. Incidence of ketoacidosis

    Time frame: Baseline to 90 days post discharge

    reporting ketoacidosis

  9. Serum glucose covariate adjusted for baseline with attention to both elevation

    Time frame: Baseline to hospital discharge, an average of 5-6 days.

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

  10. Incidence of symptomatic, sustained hypovolemic hypotension

    Time frame: Baseline to hospital discharge, an average of 5-6 days.

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

  11. In-hospital mortality

    Time frame: Baseline to hospital discharge, an average of 5-6 days.

    incidence of mortality

  12. Hospital readmission within 90 days of discharge for heart failure

    Time frame: within 90 post discharge

    Re-hospitalization within 90 days from hospital discharge

  13. Incidence of mortality within 90 days from discharge due cardiovascular cause

    Time frame: within 90 post discharge

    Incidence of mortality

  14. The incidence of worsening of renal function

    Time frame: Baseline 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

  15. Any reported adverse events during follow up period.

    Time frame: within 90 post discharge

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

  16. The progression of heart failure severity

    Time frame: within 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

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Collaborators

  • Cairo University
  • National Heart Institute, Egypt

Registry information

Official study title

Efficacy and Safety of Early Initiation of Canagliflozin in Patients With Acute Decompansted Heart Failure

Acronym: The CANA -AHF

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
May 6, 2022
Registry last updated
Jul 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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