EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease (EMPA-PRED)

December 10, 2024 updated by: National Taiwan University Hospital

The Safety and Efficacy of Empagliflozin in Patients With End-stage Renal Disease and Heart Failure With Preserved Ejection Fraction - a Randomized Controlled 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Taiwan
      • Hsinchu, Taiwan, 300
        • Recruiting
        • National Taiwan University Hospital Hsinchu branch
        • Contact:
        • Principal Investigator:
          • Chih-Cheng Wu, PhD
      • Taipei, Taiwan, 111
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:
        • Principal Investigator:
          • Donna SH Lin, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: empagliflozin
Jardiance, 25 mg, QD, for 6 months
Drug: Empagliflozin 25 MG
The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.
Other Names:
  • Jardiance 25 MG
Placebo Comparator: Placebo
QD, for 6 months
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)
Time Frame: 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
24 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV end-systolic volume index
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
LV end-diastolic volume index
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
LA volume index
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
LV ejection fraction
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
Left ventricular mass index
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
Global longitudinal strain
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
LA strain
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
Mitral inflow deceleration time
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
Mitral inflow deceleration time LV relative wall thickness
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
Tricuspid regurgitation peak gradient (TRPG)
Time Frame: 12 weeks and 24 weeks of treatment
As assessed by echocardiography, performed on non-dialysis day
12 weeks and 24 weeks of treatment
NT-proBNP
Time Frame: 4 weeks, 12 weeks and 24 weeks of treatment
Blood tests obtained pre-dialysis session
4 weeks, 12 weeks and 24 weeks of treatment
HbA1c
Time Frame: 4 weeks, 12 weeks and 24 weeks of treatment
Blood tests obtained pre-dialysis session
4 weeks, 12 weeks and 24 weeks of treatment
Lipid profile
Time Frame: 4 weeks, 12 weeks and 24 weeks of treatment
Blood tests obtained pre-dialysis session
4 weeks, 12 weeks and 24 weeks of treatment
KCCQ-OS
Time Frame: 12 weeks and 24 weeks of treatment
Performed on non-dialysis day
12 weeks and 24 weeks of treatment
6-minute walking distance
Time Frame: 12 weeks and 24 weeks of treatment
Performed on non-dialysis day
12 weeks and 24 weeks of treatment
3-minute heart rate variability
Time Frame: 12 weeks and 24 weeks of treatment
During hemodialysis session
12 weeks and 24 weeks of treatment
Blood pressure
Time Frame: 12 weeks and 24 weeks of treatment
Obtained pre-dialysis session
12 weeks and 24 weeks of treatment
Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke)
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Lower extremity non-traumatic amputation or revascularization
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
All-cause mortality
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Hospitalization for heart failure
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Hypoglycemic events
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Diabetic ketoacidosis
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Urinary tract infection
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Genital tract infection
Time Frame: 24 weeks of treatment
By medical record confirmation and by interview
24 weeks of treatment
Hypokalemia
Time Frame: 4 weeks, 12 weeks and 24 weeks of treatment
Blood tests obtained pre-dialysis session
4 weeks, 12 weeks and 24 weeks of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

Shin Kong Wu Ho-Su Memorial Hospital

Investigators

  • Principal Investigator: Chih-Cheng Wu, MD. PhD, National Taiwan University Hsin-Chu Hospital
  • Principal Investigator: Donna SH Lin, MD, Shin Kong Wu Ho-Su Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 31, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301126MINC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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