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

NCT06249945 | Recruiting Phase 4

• 1 other identifier: 202301126MINC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Heart Failure With Preserved Ejection Fraction; End Stage Renal Disease on Dialysis

Keywords

end-stage renal disease; sodium-glucose co-transporter 2 inhibitors; heart failure; diastolic function; empagliflozin

Outcome Measures

Primary Outcomes (1)

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

  As assessed by echocardiography, performed on non-dialysis day

  24 weeks of treatment

Secondary Outcomes (26)

• LV end-systolic volume index

  12 weeks and 24 weeks of treatment

• LV end-diastolic volume index

  12 weeks and 24 weeks of treatment

• LA volume index

  12 weeks and 24 weeks of treatment

• LV ejection fraction

  12 weeks and 24 weeks of treatment

• Left ventricular mass index

  12 weeks and 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 25 MG

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 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.

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 =\<40% 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, 300, Taiwan

RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111, Taiwan

RECRUITING

Related Publications (22)

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  PMID: 34449189 BACKGROUND

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  PMID: 40855136 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Heart Failure

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; Heart Diseases; Cardiovascular Diseases

Study Officials

• Donna SH 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 SH 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 21, 2024
• First Posted: February 8, 2024
• Study Start: March 5, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 16, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)