RecruitingPhase 4NCT06249945

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

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

Sponsor

National Taiwan University Hospital

Enrollment

150 participants

Start Date

Mar 5, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether empagliflozin (a drug used for diabetes and heart failure) is safe and beneficial for people with heart failure with preserved ejection fraction (HFpEF) — where the heart muscle still contracts normally but the heart is stiff — who are also on dialysis for end-stage kidney disease. This combination is rarely studied. **You may be eligible if...** - You are 20 or older - You are on regular dialysis for end-stage kidney disease, with a stable weight for the past 6 months - You have a confirmed diagnosis of HFpEF based on a standard diagnostic score **You may NOT be eligible if...** - You have very severe heart failure (NYHA Class IV) - You were hospitalized for heart failure in the past month - You have had a heart attack, stroke, or TIA recently - You have active urinary or genital infections - You have severe peripheral artery disease - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGEmpagliflozin 25 MG

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

DRUGPlacebo

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.