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

NCT06249945 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-12-16

No results posted yet for this study

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

Interventions

DRUG

Empagliflozin 25 MG

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

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.

Sponsors & Collaborators

  • Shin Kong Wu Ho-Su Memorial Hospital

    collaborator OTHER

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Donna SH Lin, MD · Shin Kong Wu Ho-Su Memorial Hospital

  • Chih-Cheng Wu, MD. PhD · National Taiwan University Hsin-Chu Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2027-12-31
Completion
2030-12-31

Countries

  • Taiwan

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249945 on ClinicalTrials.gov