EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Empagliflozin 25 MG
DrugThe medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
Placebo
DrugThe 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: empagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 treatmentSecondary outcomes
1
LV end-systolic volume index
As assessed by echocardiography, performed on non-dialysis day
Time frame
12 weeks and 24 weeks of treatment2
LV end-diastolic volume index
As assessed by echocardiography, performed on non-dialysis day
Time frame
12 weeks and 24 weeks of treatment3
LA volume index
As assessed by echocardiography, performed on non-dialysis day
Time frame
12 weeks and 24 weeks of treatment4
LV ejection fraction
As assessed by echocardiography, performed on non-dialysis day
Time frame
12 weeks and 24 weeks of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
Shin Kong Wu Ho-Su Memorial Hospital
Collaborator
Source ClinicalTrials.gov