Actively Recruiting
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Led by National Taiwan University Hospital · Updated on 2024-12-16
150
Participants Needed
2
Research Sites
356 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
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.
CONDITIONS
Official Title
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age �3E�3D 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 �3E�3D5 on the HFA-PEFF diagnostic algorithm.
You will not qualify if you...
- 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 �3C=40% by any imaging modality within 1 month of screening
- Refused informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
National Taiwan University Hospital Hsinchu Branch
Hsinchu, Taiwan, 300
Actively Recruiting
2
Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan, 111
Actively Recruiting
Research Team
D
Donna SH 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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