Actively Recruiting
Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease
Led by National Taiwan University Hospital · Updated on 2024-12-13
95
Participants Needed
2
Research Sites
354 weeks
Total Duration
On this page
Sponsors
N
National Taiwan University Hospital
Lead Sponsor
S
Shin Kong Wu Ho-Su Memorial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.
CONDITIONS
Official Title
Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- Diagnosed with end-stage renal disease under chronic, maintenance hemodialysis with stable dry weight for the past 6 months
- Documented left ventricular ejection fraction less than 50% by any imaging method within 1 month of screening
You will not qualify if you...
- Age under 20 years
- Ongoing pregnancy
- New York Heart Association (NYHA) class IV heart failure
- Hospitalization for heart failure within the past month
- Current acute urinary tract infection at screening
- Known acute genital infection
- Severe peripheral artery disease (Rutherford category 4-6)
- Acute coronary syndrome, stroke, or transient ischemic attack within the past month
- Started chronic maintenance hemodialysis within the past 6 months
- Dry weight changes greater than 5% of body weight within the past month
- Documented left ventricular ejection fraction 50% or higher by any imaging method within 1 month of screening
- Refusal to provide informed consent
AI-Screening
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Trial Site Locations
Total: 2 locations
1
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan, Taiwan, 300
Actively Recruiting
2
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, Taiwan, 111
Actively Recruiting
Research Team
D
Donna Shu-Han Lin, MD
CONTACT
H
Hao-Yun Lo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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