A Phase 4 interventional study of Empagliflozin 25 MG and Placebo in Heart Failure With Preserved Ejection Fraction and End Stage Renal Disease on Dialysis, sponsored by National Taiwan University Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by National Taiwan University Hospital · Phase 4, Interventional, and Treatment
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.
2,121 studies on the registry are indexed under Kidney Failure, Chronic; 264 are open to participants now.
This study's planned enrollment of 150 is above the median of 55 across 1,582 interventional studies indexed under Kidney Failure, Chronic.
Browse Kidney Failure, Chronic studies →National Taiwan University Hospital is the lead sponsor of 2,608 studies on the registry; 573 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Jardiance, 25 mg, QD, for 6 months
Drug: Empagliflozin 25 MG
QD, for 6 months
Drug: Placebo
The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
Also known as: Jardiance 25 MG
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.
Mitral 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
Plan to share: No
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Studies of the drug tested here: Empagliflozin
National Taiwan University Hospital →