Dapagliflozin for Acute Heart Failure

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
TIMI Study Group, Boston, MAAcute Heart Failure+1 MoreDapagliflozin - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Acute Heart Failure
  • Heart Failure

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 6 Secondary · Reporting Duration: 2 months

2 months
CV death
Cardiovascular (CV) death or worsening heart failure
Composite CV death, rehospitalization for heart failure
Composite CV death, rehospitalization for heart failure, urgent heart failure visit
Death
Readmission
Rehospitalization for heart failure, urgent heart failure visit
Symptomatic hypotension
Worsening renal function

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

Dapagliflozin
20%Cervicovaginal infection
13%Urinary tract infections
This histogram enumerates side effects from a completed 2018 Phase 4 trial (NCT03006471) in the Dapagliflozin ARM group. Side effects include: Cervicovaginal infection with 20%, Urinary tract infections with 13%.

Trial Design

2 Treatment Groups

Dapagliflozin
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

2400 Total Participants · 2 Treatment Groups

Primary Treatment: Dapagliflozin · Has Placebo Group · Phase 4

Dapagliflozin
Drug
Experimental Group · 1 Intervention: Dapagliflozin · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dapagliflozin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 months

Who is running the clinical trial?

The TIMI Study GroupLead Sponsor
12 Previous Clinical Trials
79,911 Total Patients Enrolled
AstraZenecaIndustry Sponsor
4,015 Previous Clinical Trials
240,370,458 Total Patients Enrolled
Worldwide Clinical TrialsOTHER
56 Previous Clinical Trials
11,721 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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Frequently Asked Questions

Is this experiment the initial implementation of its kind?

"At present, there are 63 active trials for Dapagliflozin being conducted in 235 cities and 50 countries. This drug was initially trialled by AstraZeneca back in 2014; the study involved 700 individuals and successfully completed its initial drug approval stage. Since then, a total of 18457 clinical trial have been concluded." - Anonymous Online Contributor

Unverified Answer

Is this trial currently recruiting participants?

"This study, which had its inception on September 24th of 2020, is still actively recruiting participants per the information available on clinicaltrials.gov. Its most recent edit was made on December 9th 2021." - Anonymous Online Contributor

Unverified Answer

What conditions are generally treated by administering Dapagliflozin?

"Dapagliflozin is widely prescribed for pharmaceutical preparations, as well as multiple other medical conditions including diet-related illnesses, exercise-induced health issues, and an insufficient response to monotherapy." - Anonymous Online Contributor

Unverified Answer

How many participants are being treated as part of this trial?

"Affirmative. According to the information displayed on clinicaltrials.gov, this trial was first published in September of 2020 and has since been revised as recently as December 2021. Currently 2400 participants have signed up and are enrolled at one site." - Anonymous Online Contributor

Unverified Answer

How does Dapagliflozin impact patient safety?

"There is ample evidence confirming dapagliflozin's safety, so it scored a 3." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.