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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
95
The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
The placebo tablet is manufactured by Prince Pharmaceutical Co., Ltd, a leading manufacturer of nutritional supplements with certifications including cGMP, GMP, ISO, and HACCP. The Prince Pharmaceutical also provides Original Equipment Manufacturing (OEM)/Original Design Manufacturing (ODM) services for a wide array of tablet shapes, and post-processing techniques such as film coating and sugar coating.
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan, Taiwan
RECRUITINGShin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, Taiwan
RECRUITINGLeft ventricular mass
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
Left ventricular mass index
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
LV end-systolic volume index
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
LV end-diastolic volume index
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
LA volume index
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
LV ejection fraction
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
Global longitudinal strain
As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day
Time frame: 24 weeks of treatment
LV end-systolic volume index
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
LV end-diastolic volume index
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
LA volume index
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
LV ejection fraction
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
Left ventricular mass index
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
Global longitudinal strain
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
LV relative wall thickness
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
Mitral inflow deceleration time
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
Tricuspid regurgitation peak gradient (TRPG)
As assessed by echocardiography, performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
NT-proBNP
Blood tests obtained pre-dialysis session
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
HbA1c
Blood tests obtained pre-dialysis session
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
Lipid profile
Blood tests obtained pre-dialysis session
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
KCCQ-OS
Performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
6-minute walking distance
Performed on non-dialysis day
Time frame: 12 weeks and 24 weeks of treatment
3-minute heart rate variability
During hemodialysis session
Time frame: 12 weeks and 24 weeks of treatment
Blood pressure
Obtained pre-dialysis session
Time frame: 12 weeks and 24 weeks of treatment
Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke)
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
Lower extremity non-traumatic amputation or revascularization
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
All-cause mortality
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
Hospitalization for heart failure
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
Hypoglycemic events
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
Hypokalemia
Blood tests obtained pre-dialysis session
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
Diabetic ketoacidosis
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
Urinary tract infection
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
Genital tract infection
By medical record confirmation and by interview
Time frame: 24 weeks of treatment
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