Canagliflozin in Patients With Acute Decompansted Heart Failure

NCT05364190 | Completed Phase 3 DMC

• 1 other identifier: CL (2973)
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Heart Failure; Acute Heart Failure; Diabetes Mellitus

Keywords

Canagliflozin; Hospitalized heart failure patients; I.V loop diuretic; NT-proBNP

Outcome Measures

Primary Outcomes (1)

• The cumulative mean of daily diuresis

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

  After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier

Secondary Outcomes (16)

• Measuring diuretic response

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

• The change in the level of NT-pro BNP

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

• Presence of symptoms of congestion and dyspnea at discharge

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

• Intensive care unit (ICU) length of stay

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

• The incidence of worsening of heart failure case

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

Study Arms (2)

Group A(Intervention group)

EXPERIMENTAL

patients 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

Drug: Canagliflozin

Group B

ACTIVE COMPARATOR

patients 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

Drug: Empagliflozin

Interventions

Canagliflozin DRUG

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

Group A(Intervention group)

Empagliflozin DRUG

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

Group B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead
• Cairo University: collaborator
• National Heart Institute, Egypt: collaborator

Study Sites (1)

National heart institute

Giza, Egypt

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Canagliflozin; empagliflozin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer ,MSc

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 6, 2022
• Study Start: June 4, 2022
• Primary Completion: December 1, 2023
• Study Completion: March 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 2024

Locations

EG (1)