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SGLT2 Inhibitor

Dapagliflozin for Acute Heart Failure

Phase 4
Recruiting
Research Sponsored by The TIMI Study Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Elevated NT-proBNP or BNP during current hospitalization based on LVEF
Currently hospitalized for AHF with specific criteria for presentation and intensification of therapy
Must not have
Symptomatic hypotension in the past 24 hours
History of end-stage liver disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial is testing whether dapagliflozin can improve the clinical outcome for people who have been hospitalized for acute heart failure, compared to placebo.

Who is the study for?
This trial is for adults hospitalized with acute heart failure who are stable after treatment. They should have a history of heart failure, no untreated serious arrhythmias or heart blocks, and not be at risk of pregnancy. People with type 1 diabetes, severe kidney issues, recent major heart procedures or those on certain other treatments can't join.
What is being tested?
The study tests if starting dapagliflozin in the hospital helps prevent cardiovascular death or worsening heart failure compared to a placebo. It's an international study where patients are randomly assigned to either the drug or placebo group while still hospitalized.
What are the potential side effects?
Dapagliflozin may cause dehydration, low blood pressure, genital yeast infections, urinary tract infections (UTIs), increased cholesterol levels and there's a rare risk of diabetic ketoacidosis even in those without diabetes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart function test shows elevated levels during this hospital stay.
Select...
I am in the hospital for acute heart failure and meet specific treatment criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have experienced symptoms of low blood pressure in the last day.
Select...
I have a history of severe liver disease.
Select...
I have type 1 diabetes or have had diabetic ketoacidosis.
Select...
My kidney function is very low or getting worse quickly.
Select...
I have had or plan to have heart device implantation or valve surgery within 30 days.
Select...
I had a heart attack or heart surgery within the last 30 days or plan to have heart surgery during the trial.
Select...
I am currently receiving two or more IV drugs to strengthen my heart muscle.
Select...
I am currently using or have had a bad reaction to SGLT2 inhibitors.
Select...
I have heart rhythm problems that haven't been treated with a device.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cardiovascular (CV) death or worsening heart failure
Secondary study objectives
CV death
Composite CV death, rehospitalization for heart failure
Composite CV death, rehospitalization for heart failure, urgent heart failure visit
+3 more
Other study objectives
Symptomatic hypotension
Worsening renal function

Side effects data

From 2018 Phase 4 trial • 30 Patients • NCT03006471
20%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapagliflozinExperimental Treatment1 Intervention
Dapagliflozin 10 mg administered orally once daily for 2 months
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo administered orally once daily for 2 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
2014
Completed Phase 4
~64440

Find a Location

Who is running the clinical trial?

The TIMI Study GroupLead Sponsor
12 Previous Clinical Trials
81,035 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,403 Previous Clinical Trials
289,122,469 Total Patients Enrolled
90 Trials studying Heart Failure
171,327 Patients Enrolled for Heart Failure
Worldwide Clinical TrialsOTHER
64 Previous Clinical Trials
12,375 Total Patients Enrolled
1 Trials studying Heart Failure
1,132 Patients Enrolled for Heart Failure

Media Library

Dapagliflozin (SGLT2 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04363697 — Phase 4
Heart Failure Research Study Groups: Dapagliflozin, Placebo
Heart Failure Clinical Trial 2023: Dapagliflozin Highlights & Side Effects. Trial Name: NCT04363697 — Phase 4
Dapagliflozin (SGLT2 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04363697 — Phase 4
~47 spots leftby Jan 2025
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