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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Protocolized Diuretic Therapy for Heart Failure (DICTATE-AHF Trial)

Phase 3
Waitlist Available
Led By JoAnn Lindenfeld, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights

DICTATE-AHF Trial Summary

This trial is testing whether adding dapagliflozin to diuretic therapy can improve outcomes for people with or without type 2 diabetes who are hospitalized with acute decompensated heart failure.

Eligible Conditions
  • Heart Failure
  • Type 2 Diabetes

DICTATE-AHF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Change in Weight (Kilograms) Per 40mg of IV Furosemide Equivalents, Adjusted for Baseline Weight
Secondary outcome measures
Hospital Readmission
Number of Participants With Inpatient Worsening Heart Failure

Side effects data

From 2023 Phase 3 trial • 240 Patients • NCT04298229
8%
Hypoglycemia
7%
HF exacerbation
4%
Death
1%
Severe Hypotension
1%
Acute Kidney Injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Structured Usual Care
Dapagliflozin + Structured Usual Care

DICTATE-AHF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Protocolized diuretic therapy plus SGLT2 inhibitor therapyExperimental Treatment2 Interventions
The patients with diabetes will receive standard of care point of care blood glucose monitoring 4 times daily (before meals and at bedtime) and sliding scale insulin. The initial loop diuretic regimen after enrollment: Loop diuretic naïve: If the patient does not take a scheduled loop diuretic as an outpatient, the initial IV loop diuretic dose will be 40mg of furosemide equivalents every 12 hours. Chronic, oral loop diuretic therapy: If the patient takes a scheduled loop diuretic regimen as an outpatient prior to hospital admission, the initial IV loop diuretic daily dose will be 2 times the total daily home regimen dose. Diuretic therapy will be titrated to goal urine output using a standardized diuretic protocol. The patient will receive SGLT2 inhibitor therapy with dapagliflozin 10 mg orally once daily until 5 days or hospital discharge.
Group II: Protocolized diuretic therapyActive Control1 Intervention
The patients with diabetes will receive standard of care point of care blood glucose monitoring 4 times daily (before meals and at bedtime) and sliding scale insulin. The initial loop diuretic regimen after enrollment: Loop diuretic naïve: If the patient does not take a scheduled loop diuretic as an outpatient, the initial IV loop diuretic dose will be 40mg of furosemide equivalents every 12 hours. Chronic, oral loop diuretic therapy: If the patient takes a scheduled loop diuretic regimen as an outpatient prior to hospital admission, the initial IV loop diuretic daily dose will be 2 times the total daily home regimen dose. Diuretic therapy will be titrated to goal urine output using a standardized diuretic protocol.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin 10 MG
2019
Completed Phase 4
~310

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
850 Previous Clinical Trials
668,887 Total Patients Enrolled
12 Trials studying Heart Failure
4,773 Patients Enrolled for Heart Failure
AstraZenecaIndustry Sponsor
4,240 Previous Clinical Trials
288,521,380 Total Patients Enrolled
81 Trials studying Heart Failure
157,972 Patients Enrolled for Heart Failure
JoAnn Lindenfeld, MDPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
1,381 Total Patients Enrolled
2 Trials studying Heart Failure
1,381 Patients Enrolled for Heart Failure

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide more context on how Protocolized Diuretic Therapy has been studied before?

"Protocolized Diuretic Therapy was first trialed in 2014 at The University of Texas Health Science Center at San Antonio. So far, there have been a total of 174 completed trials. Currently, 67 trials are still active, with a large portion of these taking place in Jackson, Mississippi."

Answered by AI

What is the mortality rate for people who undergo Protocolized Diuretic Therapy?

"Protocolized Diuretic Therapy has been studied in multiple phase 3 trials, so it has been determined to be safe."

Answered by AI

What conditions usually warrant Protocolized Diuretic Therapy?

"Protocolized Diuretic Therapy is a broad category of treatment that encompasses pharmaceuticals, diet and lifestyle changes, and other monotherapies."

Answered by AI

Are there other hospitals in the state conducting this trial?

"There are a total of 12 different clinical trial sites, 6 of which are actively recruiting patients. The locations include the University of Mississippi Medical Center in Jackson, INTEGRIS in Oklahoma City, and Saint Thomas West Hospital in Chapel Hill."

Answered by AI

How many people fit the bill to join this experiment?

"That is accurate. According to the information provided on clinicaltrials.gov, this study is looking for 240 subjects at 6 different sites. The posting date was April 1st, 2020 and the most recent update was February 1st, 2022."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
How old are they?
65+
What site did they apply to?
University of Mississippi Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
~49 spots leftby Mar 2025