DAPAgliflozin for renal protection in heart transplant recipients. Rationale and design of the randomized controlled

Stine Holmen1, Olivier Manintveld2, Kevin Damman3

  • 1Department of Cardiology, Oslo University Hospital, Oslo, Norway; Department of Medicine, Innlandet Hospital Trust, Hamar, Norway; Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Norway.

American Heart Journal
|August 21, 2025
PubMed

Insights

The DAPARHT trial investigates if dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can protect kidney function in heart transplant recipients. This study will provide the first randomized evidence on SGLT2i efficacy in this population.

Area of Science:

  • Cardiology
  • Nephrology
  • Pharmacology

Background:

  • Heart transplantation is a vital treatment for end-stage heart failure.
  • Kidney function frequently declines post-heart transplantation.
  • Sodium-glucose cotransporter 2 inhibitors (SGLT2i) are known to slow kidney function decline in other patient groups.

Purpose of the Study:

  • To evaluate the effect of dapagliflozin on kidney function in heart transplant recipients.
  • To assess the efficacy of SGLT2i in preserving estimated glomerular filtration rate (eGFR) after heart transplantation.

Main Methods:

  • The DAPAgliflozin for Renal protection in Heart Transplant recipients (DAPARHT) trial is a double-blind, randomized, placebo-controlled study.
  • Adult heart transplant recipients (at least one year post-transplant, eGFR ≥ 25 mL/min/1.73m² ) will receive 10 mg dapagliflozin or placebo for 12 months.
  • The primary endpoint is the chronic slope of eGFR from two weeks to 12 months; a 24-month open-label phase will follow.

Main Results:

  • Enrollment is ongoing, with 300 of 430 patients enrolled as of December 18th, 2024.
  • Mean baseline creatinine is 104 ± 28 μmol/L, with a mean eGFR of 66 ± 22 mL/min/1.73m².
  • The study is expected to conclude with the last patient visit in September 2028.

Conclusions:

  • The DAPARHT trial will provide the first randomized evidence on the efficacy of SGLT2i in heart transplant recipients.
  • The study aims to determine if dapagliflozin can improve the eGFR slope compared to placebo over one year.
Abstract

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