The presence of CKD has been linked to the development of HFpEF. Currently, the treatment for HFpEF is limited. SGLT2i are one of the few drug classes that have proven efficacy in HFpEF in randomized controlled trials. The results of mechanistic studies suggest that the benefits of SGLT2i on diastolic heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Despite the significance of HFpEF in patients with CKD, patients with advanced kidney disease have been excluded from studies investigating anti-heart failure drugs. The effects of SGLT2i in patients under maintenance dialysis are largely unknown. Past pharmacokinetics and pharmacodynamics studies on empagliflozin in patients with end-stage renal disease (ESRD) demonstrated that the use of empagliflozin in patients with ESRD seemed safe, yet its efficacy remains to be explored.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
150
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
RECRUITINGShin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
RECRUITINGMitral early (E) and late (A) diastolic filling velocity ratio (E/A)
As assessed by echocardiography, 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
LA strain
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
Mitral inflow deceleration time LV relative wall thickness
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
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
Hypokalemia
Blood tests obtained pre-dialysis session
Time frame: 4 weeks, 12 weeks and 24 weeks of treatment
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