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NCT Number: NCT06249932

Empagliflozin in Heart Failure with Reduced Ejection Fraction and End Stage Renal Disease

In patients with ESRD, up to 20% of patients suffer from HFrEF, leading to significant CV morbidity and mortality. Several drug classes that provide survival benefits for patients with HFrEF, including SGLT2i, lack data regarding their efficacy and safety in patients under chronic hemodialysis. As the primary target of SGLT2i is expressed mostly in the kidneys, the efficacy of SGLT2i in patients with ESRD may be limited. On the other hand, patients with ESRD are at higher risks of experiencing cardiovascular events and may still benefit from treatment. Several mechanistic studies have demonstrated direct actions of SGLT2i on the myocardium, thus it is possible that the benefits of SGLT2i on heart failure are independent of their glycosuric actions and may still be present in anuric subjects. Furthermore, pharmacokinetics and pharmacodynamics studies on empagliflozin demonstrated that peak plasma levels of empagliflozin in subjects with renal failure/ESRD were similar to those in subjects with normal renal function. The use of empagliflozin in patients with ESRD seemed safe in terms of pharmacokinetics and pharmacodynamics, yet its efficacy remains to be explored.

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Key information

Conditions

Heart Failure With Reduced Ejection Fraction Chronic Disease Disease Attributes End Stage Renal Disease on Dialysis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications 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 hemodialysis with stable dry weight for the past 6 months
  • Documented left ventricular ejection fraction <50% by any imaging modality within 1 month of screening

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 ≥50% 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® 25mg Film-Coated Tablets

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. Left ventricular mass

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

Secondary outcomes

  1. Left ventricular mass index

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

  2. LV end-systolic volume index

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

  3. LV end-diastolic volume index

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

  4. LA volume index

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

  5. LV ejection fraction

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

  6. Global longitudinal strain

    Time frame: 24 weeks of treatment

    As assessed by cardiac magnetic resonance imaging, performed on non-dialysis day

  7. LV end-systolic volume index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  8. LV end-diastolic volume index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  9. LA volume index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  10. LV ejection fraction

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  11. Left ventricular mass index

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  12. Global longitudinal strain

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  13. LV relative wall thickness

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  14. Mitral early (E) and late (A) diastolic filling velocity ratio (E/A)

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  15. Mitral inflow deceleration time

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  16. Tricuspid regurgitation peak gradient (TRPG)

    Time frame: 12 weeks and 24 weeks of treatment

    As assessed by echocardiography, performed on non-dialysis day

  17. NT-proBNP

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

    Blood tests obtained pre-dialysis session

  18. HbA1c

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

    Blood tests obtained pre-dialysis session

  19. Lipid profile

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

    Blood tests obtained pre-dialysis session

  20. KCCQ-OS

    Time frame: 12 weeks and 24 weeks of treatment

    Performed on non-dialysis day

  21. 6-minute walking distance

    Time frame: 12 weeks and 24 weeks of treatment

    Performed on non-dialysis day

  22. 3-minute heart rate variability

    Time frame: 12 weeks and 24 weeks of treatment

    During hemodialysis session

  23. Blood pressure

    Time frame: 12 weeks and 24 weeks of treatment

    Obtained pre-dialysis session

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

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  25. Lower extremity non-traumatic amputation or revascularization

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  26. All-cause mortality

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  27. Hospitalization for heart failure

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  28. Hypoglycemic events

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  29. Hypokalemia

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

    Blood tests obtained pre-dialysis session

  30. Diabetic ketoacidosis

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  31. Urinary tract infection

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

  32. Genital tract infection

    Time frame: 24 weeks of treatment

    By medical record confirmation and by interview

Study contacts

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

Donna Shu-Han 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 Reduced Ejection Fraction - a Randomized Controlled Trial

Acronym: EMPA-RRED

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Feb 8, 2024
Registry last updated
Dec 13, 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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