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DAPAgliflozin for Renal Protection in Heart Transplant Recipients

Study acronym: DAPARHT
StatusActive, Not Recruiting
PhasePhase 3
Started2022-06-08
View on ClinicalTrials.gov ↗

Amendment history

2026-06-29
notable
Recruiting→Active, Not Recruiting Study Status, Oversight, Outcome Measures, Contacts/Locations, Document Section v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2026-04-30→2028-09-30
Completion date2028-05-31→2028-11-30
Primary endpoints1 to 2 entries
The change in eGFR from baseline
Study sites6 entries, revised
Sahlgrenska University HospitalMedical Center Utrecht
2024-10-01
minor
Study Status, Oversight, Contacts/Locations v3
Primary completion date2025-06-30→2026-04-30
Completion date2027-06-30→2028-05-31
Study sites6 entries, revised
Aarhus University HospitalMedical Center Groningen
2023-11-07
minor
Study Status, Contacts/Locations v2
Primary completion date2023-06-30→2025-06-30
Completion date2024-06-30→2027-06-30
Study sitesdetails revised at 1 of 6 sites
2022-09-01
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-04-11→confirmed 2022-06-08
Study sitesdetails revised at 6 of 6 sites
2022-04-04
minor
Original filing
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.
Trial Details
NCT Number NCT05321706
Lead Sponsor Oslo University Hospital
Collaborators: Erasmus Medical Center, Skane University Hospital, Aarhus University Hospital, Karolinska University Hospital, Sahlgrenska University Hospital
Conditions Heart Transplant Failure, Kidney Failure
Enrollment 430 participants
Start Date 2022-06-08
Primary Completion 2028-09-30 (estimated)
Study Completion 2028-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-01