EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
- Conditions
- Heart Failure With Preserved Ejection FractionEnd Stage Renal Disease on Dialysis
- Interventions
- Drug: Placebo
- Registration Number
- NCT06249945
- Lead Sponsor
- National Taiwan University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 150
- Age ≥20 years old
- ESRD under chronic, maintenance dialysis with stable dry weight for the past 6 months
- Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnostic algorithm.
- Age <20 years old
- Ongoing pregnancy
- NYHA class IV heart failure
- Any hospitalization for heart failure within the past month Ongoing acute urinary tract infection at the time of 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
- Recent initiation of chronic maintenance hemodialysis within 6 months
- Adjustment of dry weight with changes greater than 5% of body weight within the past month
- Documented left ventricular ejection fraction =<40% by any imaging modality within 1 month of screening
- Refused informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo QD, for 6 months empagliflozin Empagliflozin 25 MG Jardiance, 25 mg, QD, for 6 months
- Primary Outcome Measures
Name Time Method Mitral early (E) and late (A) diastolic filling velocity ratio (E/A) 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
- Secondary Outcome Measures
Name Time Method Blood pressure 12 weeks and 24 weeks of treatment Obtained pre-dialysis session
Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke) 24 weeks of treatment By medical record confirmation and by interview
Lower extremity non-traumatic amputation or revascularization 24 weeks of treatment By medical record confirmation and by interview
All-cause mortality 24 weeks of treatment By medical record confirmation and by interview
LV end-systolic volume index 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
LV end-diastolic volume index 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
LA volume index 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
Hospitalization for heart failure 24 weeks of treatment By medical record confirmation and by interview
LV ejection fraction 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
Hypoglycemic events 24 weeks of treatment By medical record confirmation and by interview
Left ventricular mass index 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
Global longitudinal strain 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
LA strain 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
Mitral inflow deceleration time 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
Mitral inflow deceleration time LV relative wall thickness 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
Tricuspid regurgitation peak gradient (TRPG) 12 weeks and 24 weeks of treatment As assessed by echocardiography, performed on non-dialysis day
NT-proBNP 4 weeks, 12 weeks and 24 weeks of treatment Blood tests obtained pre-dialysis session
HbA1c 4 weeks, 12 weeks and 24 weeks of treatment Blood tests obtained pre-dialysis session
Lipid profile 4 weeks, 12 weeks and 24 weeks of treatment Blood tests obtained pre-dialysis session
KCCQ-OS 12 weeks and 24 weeks of treatment Performed on non-dialysis day
6-minute walking distance 12 weeks and 24 weeks of treatment Performed on non-dialysis day
3-minute heart rate variability 12 weeks and 24 weeks of treatment During hemodialysis session
Diabetic ketoacidosis 24 weeks of treatment By medical record confirmation and by interview
Urinary tract infection 24 weeks of treatment By medical record confirmation and by interview
Genital tract infection 24 weeks of treatment By medical record confirmation and by interview
Hypokalemia 4 weeks, 12 weeks and 24 weeks of treatment Blood tests obtained pre-dialysis session
Trial Locations
- Locations (2)
National Taiwan University Hospital Hsinchu Branch
🇨🇳Hsinchu, Taiwan
Shin Kong Wu Ho-Su Memorial Hospital
🇨🇳Taipei, Taiwan