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

NCT06249932 | Recruiting Phase 4

• 1 other identifier: 202301140MINC
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure with Reduced Ejection Fraction; End Stage Renal Disease on Dialysis

Keywords

end stage renal disease; sodium-glucose co-transporter 2 inhibitors,; heart failure with reduced ejection fraction; empagliflozin; left ventricular mass

Outcome Measures

Primary Outcomes (1)

• Left ventricular mass

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

  24 weeks of treatment

Secondary Outcomes (32)

• Left ventricular mass index

  24 weeks of treatment

• LV end-systolic volume index

  24 weeks of treatment

• LV end-diastolic volume index

  24 weeks of treatment

• LA volume index

  24 weeks of treatment

• LV ejection fraction

  24 weeks of treatment

Study Arms (2)

empagliflozin

EXPERIMENTAL

Jardiance, 25 mg, QD, for 6 months

Drug: Empagliflozin 25 MG

placebo

PLACEBO COMPARATOR

QD, for 6 months

Drug: Placebo

Interventions

Empagliflozin 25 MG DRUG

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

Also known as: Jardiance® 25mg Film-Coated Tablets

empagliflozin

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.

placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator

Study Sites (2)

National Taiwan University Hospital Hsinchu Branch

Hsinchu, Taiwan, 300, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan, 111, Taiwan

RECRUITING

Related Publications (16)

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  PMID: 40855136 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Donna Shu-Han Lin, MD

  Shin Kong Wu Ho-Su Memorial Hospital

  PRINCIPAL INVESTIGATOR

• Chih-Cheng Wu, MD. PhD

  National Taiwan University Hsin-Chu Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Shu-Han Lin, MD

CONTACT

+886912902379; Donna.lin24@gmail.com

Hao-Yun Lo, MD

CONTACT

+886972234640; limoonby@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: February 8, 2024
• Study Start: March 13, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)