Dapagliflozin for Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a medication called dapagliflozin, an SGLT2 inhibitor, to determine its effectiveness for people with heart failure and acute kidney injury. Researchers aim to discover if adding this medication to usual care can improve heart and kidney health by examining survival rates and symptoms. Participants will receive either dapagliflozin or a placebo (a pill with no active medicine) for up to 14 days. This trial suits individuals with heart failure experiencing flare-ups who can take oral medication and are open to trying a new treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using an SGLT2 inhibitor or have used one in the past 72 hours.
Is there any evidence suggesting that dapagliflozin is likely to be safe for humans?
Research has shown that dapagliflozin, a type of medication, is generally safe for people with heart failure. One study found that it lowered the chances of hospitalization for heart failure, death from heart-related issues, and death from any cause. This indicates it helps keep patients out of the hospital and reduces life-threatening events.
In another study, people taking dapagliflozin had an 18% lower risk of dying from heart problems or having their heart failure worsen compared to those not taking it. This resulted in fewer serious heart-related issues, which is a positive indicator of safety.
Overall, dapagliflozin is often used for patients with heart failure, and current research supports its safety. While it works well, like any medication, it may have some side effects. However, the overall evidence shows it is safe for many patients.12345Why do researchers think this study treatment might be promising?
Dapagliflozin is unique because it works by inhibiting the SGLT2 protein in the kidneys, which helps reduce the workload on the heart. Unlike traditional heart failure treatments that primarily focus on managing symptoms or improving heart muscle function, dapagliflozin offers a novel approach by enhancing the body's ability to remove excess sodium and fluid, thus lowering blood pressure and decreasing heart strain. Researchers are excited about dapagliflozin because it not only addresses heart failure symptoms but also has the potential to improve overall heart health, offering a fresh avenue for treating this condition.
What evidence suggests that dapagliflozin might be an effective treatment for heart failure?
Research has shown that dapagliflozin, also known as Farxiga, effectively treats heart failure. Studies have found it can lower the risk of death from heart-related issues by 14% and reduce the chance of heart failure worsening by 18%. It also significantly decreases hospital visits for heart failure, with a 24% reduction in risk. This treatment is approved for heart failure with reduced ejection fraction, proving it helps patients live longer and spend less time in the hospital. These findings highlight its potential benefits for people with heart failure. Participants in this trial will receive either dapagliflozin or a placebo comparator to further evaluate its effectiveness.14678
Who Is on the Research Team?
Abinet Aklilu, MD
Principal Investigator
Yale University
Are You a Good Fit for This Trial?
This trial is for hospitalized patients with heart failure who also have acute kidney injury. Participants should be stable enough to take oral medication and not require immediate dialysis. Specific criteria may exclude some individuals based on their medical history or current health status.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either dapagliflozin or placebo for 14 days or until discharge
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Dapagliflozin
Trial Overview
The study tests if adding a drug called Dapagliflozin, which is an SGLT2 inhibitor, to the usual care for these patients can improve outcomes like survival, need for dialysis, progression of kidney injury, fluid management, and heart failure symptoms compared to a placebo.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Subjects receive once daily 10 mg of oral dapagliflozin (Farxiga) for 14 days (or until discharge). Empaglifolozin may be used in case of dapagliflozin shortage.
Subjects receive once daily administration of a placebo comparator for 14 days (or until discharge).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Citations
1.
astrazeneca.com
astrazeneca.com/content/astraz/media-centre/press-releases/2022/farxiga-lowers-risk-cv-death-heart-failure.htmlNew data show Farxiga significantly lowers the risk of ...
The analysis showed that Farxiga reduced the risk of CV death by 14% (p=0.01, absolute risk reduction [ARR] 1.5%) over the median follow-up of 22 months.
FARXIGA significantly reduced the risk of cardiovascular ...
FARXIGA reduced the composite outcome of CV death or worsening of HF by 18% (p<0.001, 16.4% in the dapagliflozin group and 19.5% (absolute risk ...
Effect of Dapagliflozin in Patients with Heart Failure
Additionally, dapagliflozin significantly reduced the hospitalization due to heart failure (RR = 0.76, 95% CI: 0.70–0.84, P > 0.00001, I2 = 0%) ...
FDA Approves New Treatment For a Type of Heart Failure
Farxiga was shown in a clinical trial to improve survival and reduce the need for hospitalization in adults with heart failure with reduced ejection fraction.
Heart Failure | FARXIGA® (dapagliflozin) 5 mg & 10 mg tablets
DAPA-HF was a randomized, placebo-controlled, HF outcomes trial of 4744 adults with HF with EF ≤40%. The study assessed whether treatment with FARXIGA reduced ...
Primary Results of the DAPA ACT HF-TIMI 68 Randomized ...
In this trial, in-hospital initiation of dapagliflozin did not significantly reduce the risk of cardiovascular death or worsening heart failure ...
Empagliflozin and Dapagliflozin Outcomes in Heart Failure
This cohort study compares the outcomes associated with use of dapagliflozin and empagliflozin in patients with heart failure.
Dapagliflozin in Patients with Heart Failure and Reduced ...
Over a median of 18.2 months, the primary outcome occurred in 386 of 2373 patients (16.3%) in the dapagliflozin group and in 502 of 2371 patients (21.2%) in the ...
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