Status:
NOT_YET_RECRUITING
Repurposing Empagliflozin and Dapagliflozin for Paediatric Heart Failure: Translational Approach and Dose Rationale
Lead Sponsor:
Centre Hospitalier Universitaire Vaudois
Collaborating Sponsors:
Great Ormond Street Hospital for Children NHS Foundation Trust
University College, London
Conditions:
Heart Failure
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
This study aims at exploring the use of Dapagliflozin and Empagliflozin in children and adolescents 6-18 years old with heart failure. These molecules are effective in reducing hospitalisations and mo...
Detailed Description
Paediatric heart failure is a relevant healthcare issue, with almost 15'000 yearly hospitalizations just in the USA. Sadly, current heart failure therapy in Paediatrics is still unsatisfactory, with h...
Eligibility Criteria
Inclusion
- Children 6 to 18 years of age, followed either as in- or outpatients at the Heart failure unit, Great Ormond Street Hospital NHS Foundation Trust, London or at the Paediatric Cardiology Unit, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne University Hospital, Lausanne, Switzerland will be eligible for inclusion.
- Currently on heart failure medication (any drug or any combination).
- Patients should potentially benefit from adding a SGLT2i (as judged by the treating physician and the local PI or Co-PI).
- Patients need to be on stable medical treatment, defined as no new heart failure drug started over the preceding 2 weeks and no major drug dose modification (apart minor adaptations, like weight adaptations, rounding or formulation changes) during the 2 weeks prior to enrolment.
- Adolescents, respectively parents or caregivers of children, capable of giving informed consent.
Exclusion
- Inability to understand and go through the informed consent procedure.
- Inability to receive medications per os or through a nasogastric tube.
- Patients on either Insulin or Metformin will be excluded from participation. This implies the exclusion of patients with Diabetes mellitus (either type 1 or type 2 or other rare forms) necessitating either insulin or metformin.
- Type 1 Diabetes mellitus or any underlying metabolic disease associated with hypoglycaemias.
- Body weight \<13kg.
- Current smokers (defined as \>1 cigarette/week).
- Use of any other nicotine-delivering product (e.g. nicotine patches).
- Any known illicit drug abuse.
- Active chronic HBV, HCV or HIV.
- Any major surgery within 4 weeks of first dose administration.
- Blood transfusion recipient within 4 weeks of dose administration.
- eGFR =\<45mL/min/1.73m2 (simplified Schwartz formula).
- K+ \>6.5mmol/L.
- Blood glucose \<4mmol/L.
- There are no blood pressure exclusion criteria foreseen, but participants need to be haemodynamically stable, as assessed by the local investigator (board-certified paediatric cardiologist).
- Sustained or symptomatic arrhythmia insufficiently controlled with drug and/or device therapy.
- Cardio-surgical procedure within the 2 months prior to Visit 1, or interventional cardiac catheterization within 2 weeks prior to Visit 1, or the patient is planned to undergo cardiac surgery or an interventional cardiac catheterization during the study period (i.e. in the 6 weeks following Visit 1).
- Post-menarchal female patients of childbearing potential cannot be included.
- Known lactose intolerance, galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.
- Known allergies to excipients of either Dapagliflozin or Empagliflozin.
- Significant medical history of active severe medical disease.
- Significant liver disease, Child Pugh Class C, or significant laboratory abnormalities at enrolment.
- Significant gastroenterological or hepatic disease that could significantly impair absorption or metabolism of orally administered drugs.
- Any medical co-morbidity, which is deemed incompatible (or only with relevant risk) with study participation by the treating clinician and/or the study investigator.
- Active urinary tract infection (being treated with antibiotics at the moment of Visit 1) or other relevant bacterial infection, as judged by the treating clinician and/or the study investigator.
- The patient is currently participating in another interventional clinical trial or has participated in such a trial during the \<14 days before Visit 1 (or if enrolment in this study is incompatible with the protocol of that preceding trial).
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06012266
Start Date
August 1 2024
End Date
August 1 2025
Last Update
February 7 2024
Active Locations (3)
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1
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland, 1011
2
University College London
London, Greater London, United Kingdom, WC1H 9JP
3
Great Ormond Street Hospital NHS Foundation Trust
London, Greater London, United Kingdom, WC1N 3JH