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NCT Number: NCT06249945

EMPAgliflozin in Heart Failure With PReserved Ejection Fraction and End Stage Renal Disease

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.

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Key information

Conditions

Heart Failure With Preserved Ejection Fraction Cardiovascular Diseases Chronic Disease Disease Attributes End Stage Renal Disease on Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Heart Failure Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Taiwan University Hospital Hsinchu Branch, Hsinchu, Taiwan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Empagliflozin 25 MG

Drug

The medication will be packed in a customized sealed jar and labeled on the exterior of the jar.

Other names: Jardiance 25 MG

Placebo

Drug

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. LV end-systolic volume index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  2. LV end-diastolic volume index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  3. LA volume index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  4. LV ejection fraction

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  5. Left ventricular mass index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  6. Global longitudinal strain

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  7. LA strain

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  8. Mitral inflow deceleration time

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  9. 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

  10. Tricuspid regurgitation peak gradient (TRPG)

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  11. NT-proBNP

    Time frame: 4 weeks, 12 weeks and 24 weeks of treatment

    Blood tests obtained pre-dialysis session

  12. HbA1c

    Time frame: 4 weeks, 12 weeks and 24 weeks of treatment

    Blood tests obtained pre-dialysis session

  13. Lipid profile

    Time frame: 4 weeks, 12 weeks and 24 weeks of treatment

    Blood tests obtained pre-dialysis session

  14. KCCQ-OS

    Time frame: 12 weeks and 24 weeks of treatment

    Performed on non-dialysis day

  15. 6-minute walking distance

    Time frame: 12 weeks and 24 weeks of treatment

    Performed on non-dialysis day

  16. 3-minute heart rate variability

    Time frame: 12 weeks and 24 weeks of treatment

    During hemodialysis session

  17. Blood pressure

    Time frame: 12 weeks and 24 weeks of treatment

    Obtained pre-dialysis session

  18. Major adverse cardiovascular events (composite of CV death, myocardial infarction, stroke)

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  19. Lower extremity non-traumatic amputation or revascularization

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  20. All-cause mortality

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  21. Hospitalization for heart failure

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  22. Hypoglycemic events

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  23. Diabetic ketoacidosis

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  24. Urinary tract infection

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  25. Genital tract infection

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  26. Hypokalemia

    Time frame: 4 weeks, 12 weeks and 24 weeks of treatment

    Blood tests obtained pre-dialysis session

Study contacts

Contact information is provided by the study sponsor or research team.

Donna SH Lin, MD

CONTACT

[email protected]

+886912902379

Hao-Yun Lo, MD

CONTACT

[email protected]

+886972234640

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Shin Kong Wu Ho-Su Memorial Hospital

Registry information

Official study title

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

Acronym: EMPA-PRED

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Feb 8, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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