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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months
Awards & highlights
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.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cardiovascular (CV) death or worsening heart failure
Secondary outcome measures
CV death
Composite CV death, rehospitalization for heart failure
Composite CV death, rehospitalization for heart failure, urgent heart failure visit
+3 moreOther outcome measures
Symptomatic hypotension
Worsening renal function
Side effects data
From 2018 Phase 4 trial • 30 Patients • NCT0300647120%
Cervicovaginal infection
13%
Urinary tract infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dapagliflozin
Placebo
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
~64880
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
4,259 Previous Clinical Trials
288,591,502 Total Patients Enrolled
84 Trials studying Heart Failure
163,626 Patients Enrolled for Heart Failure
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
11,987 Total Patients Enrolled
1 Trials studying Heart Failure
1,132 Patients Enrolled for Heart Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have type 1 diabetes or have had diabetic ketoacidosis.I am in the hospital for acute heart failure and meet specific treatment criteria.I have experienced symptoms of low blood pressure in the last day.My kidney function is very low or getting worse quickly.I have had or plan to have heart device implantation or valve surgery within 30 days.You have had a heart transplant, used a mechanical heart pump, or have specific types of heart failure.Your heart's pumping ability has been measured within the past year.I had a heart attack or heart surgery within the last 30 days or plan to have heart surgery during the trial.People with and without type 2 diabetes can take part in the study.I have a history of heart failure.I am 18 years old or older.I am currently receiving two or more IV drugs to strengthen my heart muscle.I am currently using or have had a bad reaction to SGLT2 inhibitors.I was hospitalized and stabilized recently, between 1 day and 2 weeks ago.I have heart rhythm problems that haven't been treated with a device.My heart function test shows elevated levels during this hospital stay.I have a history of severe liver disease.My heart's pumping ability is within any range.
Research Study Groups:
This trial has the following groups:- Group 1: Dapagliflozin
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
How does Dapagliflozin impact patient safety?
"There is ample evidence confirming dapagliflozin's safety, so it scored a 3."
Answered by AI
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