Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-24 @ 4:36 PM
NCT ID:
NCT06012266
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT06012266
Study Brief:
Protocol Section:
NCT06012266