Dapagliflozin in Diabetic Patients (Type 2) With Decompensated Heart Failure

Sponsor
Assiut University
Study ID
NCT04385589
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Patient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome.
  • insulin — DRUG
    insulin

Study Details

We hypothesize that Dapagliflozin could improve the diuretic response in diabetic patients with acute decompensated heart failure owing to its diuretic effect in addition to improvement of blood glucose level without remarkable effect on kidney function or electrolytes.

Key Dates

Start date
May 1, 2020
Status verified
Feb 2022
Primary completion
Dec 15, 2020
Completion
Dec 20, 2020

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin group
    50 patients will receive Dapagliflozin plus insulin (if needed) and Diuretics plus conventional heart failure measures.
  • Placebo Comparator: Placebo group
    50 patients will receive insulin for control of blood sugar plus diuretics and anti-failure measures.

Primary Outcome Measure

Changes in body weight measurement (Diuresis effect.) [ Time Frame: Days of admission (3-5 days) ]

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