MedTrace Logo

Efficacy and Safety of Dapagliflozin in Acute Heart Failure

NCT04298229 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2024-03-15

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Dapagliflozin 10 MG

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

OTHER

Protocolized Diuretic Therapy

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

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • JoAnn Lindenfeld, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2023-05-17
Completion
2023-05-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04298229 on ClinicalTrials.gov