Repurposing Empagliflozin and Dapagliflozin for Paediatric Heart Failure: Translational Approach and Dose Rationale

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

August 31, 2024

Primary Completion Date

August 31, 2025

Study Completion Date

August 31, 2025

Conditions
Heart Failure
Interventions
DRUG

Dapagliflozin tablet

"Patients randomized to Group A will start with Dapagliflozin on Visit 1 and take Dapagliflozin once daily up to the day before Visit 3.~Patients randomized to Group B will start Dapagliflozin once daily on the day of Visit 3, to be continued up to the day preceding Visit 4.~Dose:~* participants ≤12 year old: 5mg once daily p.o. (commercially available tablet)~* participants \>12 year old: 10mg once daily p.o. (commercially available tablet)"

DRUG

Empagliflozin Tablets

"Patients randomized to Group A will start with Empagliflozin on Visit 1 and take Empagliflozin once daily up to the day before Visit 3.~Patients randomized to Group B will start Empagliflozin once daily on the day of Visit 3, to be continued up to the day preceding Visit 4.~Dose: Empagliflozin 10mg once daily p.o. (commercially available tablet)"

Trial Locations (3)

1011

Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne

WC1H 9JP

University College London, London

WC1N 3JH

Great Ormond Street Hospital NHS Foundation Trust, London

All Listed Sponsors
collaborator

Great Ormond Street Hospital for Children NHS Foundation Trust

OTHER

collaborator

University College, London

OTHER

lead

Centre Hospitalier Universitaire Vaudois

OTHER