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

Last updated: December 10, 2024
Sponsor: National Taiwan University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Chest Pain

Heart Failure

Hyponatremia

Treatment

Empagliflozin 25 MG

Placebo

Clinical Study ID

NCT06249945
202301126MINC
  • Ages > 20
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age ≥20 years old

  • ESRD under chronic, maintenance dialysis with stable dry weight for the past 6months

  • Prior diagnosis of HFpEF, as defined by a score of ≥5 on the HFA-PEFF diagnosticalgorithm.

Exclusion

Exclusion Criteria:

  • Age <20 years old

  • Ongoing pregnancy

  • NYHA class IV heart failure

  • Any hospitalization for heart failure within the past month Ongoing acute urinarytract 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 pastmonth

  • Documented left ventricular ejection fraction =<40% by any imaging modality within 1month of screening

  • Refused informed consent

Study Design

Total Participants: 150
Treatment Group(s): 2
Primary Treatment: Empagliflozin 25 MG
Phase: 4
Study Start date:
March 05, 2024
Estimated Completion Date:
December 31, 2030

Connect with a study center

  • National Taiwan University Hospital Hsinchu Branch

    Hsinchu, 300
    Taiwan

    Active - Recruiting

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, 111
    Taiwan

    Active - Recruiting

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