Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017.
GBD Chronic Kidney Disease Collaboration
https://pubmed.ncbi.nlm.nih.gov/32061315Actively Recruiting
Phase 4
Age: 20Years +
All Genders
ID06249945
Safety and Efficacy of Empagliflozin in Patients With End-Stage Renal Disease and Heart Failure With Preserved Ejection Fraction: A Randomized Controlled Trial
Led by National Taiwan University Hospital · Updated on 2024-12-16
150
Participants Needed
2
Research Sites
156 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
Researchers are studying the safety and effects of empagliflozin in patients with end-stage renal disease (ESRD) who also have heart failure with preserved ejection fraction (HFpEF). While SGLT2 inhibitors like empagliflozin have shown benefits in HFpEF, their effects in patients on maintenance dialysis are not well known. This trial aims to explore empagliflozin's impact on heart function in this specific group, as previous studies excluded patients with advanced kidney disease. Participants will be randomly assigned to receive either empagliflozin 25 mg once daily or a placebo for six months. The study is single-blinded, meaning participants will not know which treatment they receive. The trial will measure heart function changes over 24 weeks, focusing on diastolic filling velocity ratios and other heart-related volumes and functions. During the study, participants will undergo multiple assessments including heart imaging at 12 and 24 weeks, blood tests measuring NT-proBNP, HbA1c, lipid profiles, and potassium levels at several time points. Quality of life questionnaires, walking tests, heart rate variability, blood pressure, and monitoring for adverse events such as infections and hypoglycemia will also be conducted. The research team will carefully monitor heart health and safety throughout the treatment period, which lasts six months.
CONDITIONS
Brief Title
EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Who Can Participate
Age: 20Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 20 years or older
- End-stage renal disease under chronic maintenance dialysis with stable dry weight for the past 6 months
- Prior diagnosis of heart failure with preserved ejection fraction with a score of 5 or more on the HFA-PEFF diagnostic algorithm
You will not qualify if you...
- Age under 20 years
- Ongoing pregnancy
- New York Heart Association class IV heart failure
- Hospitalization for heart failure within the past month
- Acute urinary tract infection at 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 start of chronic maintenance hemodialysis within 6 months
- Dry weight adjustment greater than 5% of body weight within the past month
- Left ventricular ejection fraction 40% or less by imaging within 1 month of screening
- Refusal to give informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive either Empagliflozin 25 mg or placebo once daily for 6 months.
Visits at 4 weeks, 12 weeks, and 24 weeks during treatment
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
Loading map...
Research Team
D
Donna SH Lin, MD
H
Hao-Yun Lo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Chronic kidney disease.
Kamyar Kalantar-Zadeh, Tazeen H Jafar, Dorothea Nitsch...
https://pubmed.ncbi.nlm.nih.gov/34175022Cardiorenal syndrome.
Claudio Ronco, Mikko Haapio, Andrew A House...
https://pubmed.ncbi.nlm.nih.gov/19007588Burden and Outcomes of Heart Failure Hospitalizations in Adults With Chronic Kidney Disease.
Nisha Bansal, Leila Zelnick, Zeenat Bhat...
https://pubmed.ncbi.nlm.nih.gov/31146814Impact of Renal Impairment on Beta-Blocker Efficacy in Patients With Heart Failure.
Dipak Kotecha, Simrat K Gill, Marcus D Flather...
https://pubmed.ncbi.nlm.nih.gov/31806133Lipid management in patients with chronic kidney disease.
Charles J Ferro, Patrick B Mark, Mehmet Kanbay...
https://pubmed.ncbi.nlm.nih.gov/30361677Is Heart Failure with Preserved Ejection Fraction a Kidney Disorder?
Kevin S Shah, James C Fang
https://pubmed.ncbi.nlm.nih.gov/31599363Connecting heart failure with preserved ejection fraction and renal dysfunction: the role of endothelial dysfunction and inflammation.
Jozine M Ter Maaten, Kevin Damman, Marianne C Verhaar...
https://pubmed.ncbi.nlm.nih.gov/26861140Clinical Phenogroups in Heart Failure With Preserved Ejection Fraction: Detailed Phenotypes, Prognosis, and Response to Spironolactone.
Jordana B Cohen, Sarah J Schrauben, Lei Zhao...
https://pubmed.ncbi.nlm.nih.gov/31926856Empagliflozin in Heart Failure with a Preserved Ejection Fraction.
Stefan D Anker, Javed Butler, Gerasimos Filippatos...
https://pubmed.ncbi.nlm.nih.gov/34449189