Canagliflozin in Patients With Acute Decompansted Heart Failure

Sponsor
October 6 University
Study ID
NCT05364190
Phase
PHASE3
Status
Completed

Conditions

  • Acute Heart Failure
  • Chronic Heart Failure
  • Diabetes Mellitus

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Jun 4, 2022
Status verified
Jul 2024
Primary completion
Dec 1, 2023
Completion
Mar 1, 2024

Study Design

Enrollment
142 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A(Intervention group)
    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
  • Active Comparator: Group B
    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

Primary Outcome Measure

The cumulative mean of daily diuresis [ Time Frame: After (day1)24 hours from hospital admission and until Day 5 or discharge if earlier ]

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