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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Jan 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called empagliflozin in patients who have heart failure with preserved ejection fraction (HFpEF) and are on dialysis due to end-stage renal disease (ESRD). Patients with HFpEF have a heart that struggles to fill with blood properly, and there's a need for more effective treatments, especially in those with advanced kidney disease. The trial aims to see if empagliflozin can help improve heart function in these patients, as previous research suggests it may be beneficial even for those on dialysis.

To participate in this trial, individuals need to be at least 20 years old, have been on stable dialysis for the past six months, and have a prior diagnosis of HFpEF. Participants can expect regular check-ups and monitoring while receiving the medication, and the trial is currently recruiting patients of all genders. It's important to note that individuals with certain health conditions, such as severe heart failure or recent heart-related hospital stays, may not be eligible to join. If you or someone you know fits the criteria and is interested, this trial could be a valuable opportunity to help improve treatment options for heart failure in patients with kidney disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• 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 =\<40% by any imaging modality within 1 month of screening
• • Refused informed consent