CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Dapagliflozin 10 MG +1 moredrug
Likely dose
Dapagliflozin 10 MGfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04298229
NCT04298229Phase 3Completed
CompareCT.gov

A Randomized, Open-label Study of Dapagliflozin in Patients With or Without Type 2 Diabetes Admitted With Acute Heart Failure

Vanderbilt University Medical Center·interventional·Posted Mar 6, 2020·Updated Mar 15, 2024

In Brief

A Phase 3 clinical trial evaluating Dapagliflozin 10 MG and Protocolized Diuretic Therapy for Heart Failure and Diabetes Mellitus, Type 2. Completed, enrolled 240 participants across 6 sites.

Detailed Summary

This is a randomized trial of the addition of dapagliflozin to patients with or without type 2 diabetes hospitalized with acute decompensated heart failure (ADHF). Participants will be recruited following an initial standard evaluation in the ED and randomized within 24 hours of presentation for ADHF in a 1:1 fashion to protocolized diuretic therapy or dapagliflozin + protocolized diuretic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Diabetes Mellitus, Type 2
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedMar 6, 2020
Enrollment StartApr 1, 2020
Primary CompletionMay 17, 2023
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.3 years ago

Interventions

Dapagliflozin 10 MGdrug

SGLT2 inhibitors being investigated for its diuretic and natriuretic effects on top of protocolized diuretic therapy.

Protocolized Diuretic Therapyother

Structured usual care arm with protocolized diuretic therapy based on urine output.