DAPAgliflozin for Renal Protection in Heart Transplant Recipients

Summary

Kidney failure is common in heart transplant recipients and is a major cause of morbidity and mortality. Sodium-glucose transporter 2 (SGLT2) inhibitors were developed as antidiabetics but were subsequently shown to reduce the incidence of adverse cardiovascular outcomes and protect renal function in non-diabetics as well as diabetics. However, SGLT2 inhibitors have not been tested in clinical trials in heart transplant recipients. The DAPARHT trial is designed to assess the effect of the SGLT2 inhibitor dapagliflozin to prevent deteriorating renal function in heart transplant recipients. Secondary objectives are to assess the impact of treatment on i) weight, ii) glucose homeostasis, iii) proteinuria, iv) the number of rejections, and (v) safety and tolerability. As exploratory outcomes, the investigators will assess the effect of treatment on renal outcomes, clinical events (death, myocardial infarction, cerebral stroke, cancer, and end-stage renal disease), cardiac function, quality of life, and new-onset diabetes.

Timeline

Start

2022-06-08

Primary completion

2028-09-30

Completion

2028-11-30

Publications

• Holmen S, Manintveld O, Damman K, Braun O, Lofman IH, Szymanski M, Ravnestad H, Gude E, Bjorkelund E, Andreassen AK, Gullestad L, Broch K. DAPAgliflozin for renal protection in heart transplant recipients. Rationale and design of the randomized controlled DAPARHT trial. Am Heart J. 2026 Jan;291:128-135. doi: 10.1016/j.ahj.2025.08.010. Epub 2025 Aug 19.
• Garcia-Cosio Carmena MD, Farrero M, Blasco Peiro MT, Crespo M, Delgado Jimenez J, Diaz Molina B, Fernandez Rivera C, Garrido Bravo IP, Lopez Jimenez V, Melilli E, Mirabet Perez S, Perez Tamajon ML, Rangel Sousa D, Rodrigo E, Cruzado JM, Hernandez Marrero D; Spanish Society of Transplantation, the Spanish Society of Nephrology, and the Spanish Society of Cardiology (SET-SEC-SEN). Management of Kidney Disease in Heart Transplant Patients: A National Delphi Survey-based Consensus Expert Paper. Transplantation. 2025 Sep 1;109(9):e431-e445. doi: 10.1097/TP.0000000000005302. Epub 2025 Feb 7.

Drugs

Indications