Dapagliflozin in pediatric heart failure with reduced ejection fraction (Dapa-Ped HF) - A randomized pilot study - Dapa-Ped HF

Dr Nabeel Faisal V0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年7月25日

试验速览

暂无简介。

•1.Age 1 year to <12 years
•2.Chronic heart failure resulting from dilated cardiomyopathy and ventricular dysfunction receiving standard of care heart failure therapy
•3.NYHA class II-IV (children 6 years to <12 years) or Ross HF classification II-IV (Children <6 years) any time prior to enrolment
•4.LV ejection fraction <40% by echocardiogram
•5.Etiologies of heart failure include: Idiopathic cardiomyopathy or history of myocarditis.
•6.eGFR >=30 ml/min/1.73 m2 (Shwartz formula) at enrolment

•1.Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
•2.Patient with type I diabetes mellitus
•3.Patients with hemodynamically significant structural heart disease operated or unoperated
•4.Patients with sustained or symptomatic dysrhythmias not controlled with drug or device therapy
•5.HF due to restrictive cardiomyopathy, acute myocarditis (within 3 months of onset), constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, Familial or genetic cardiomyopathy, neuromuscular disease or uncorrected primary valvular disease
•6.Symptomatic hypotension or BP below 5th percentile systolic BP for age at enrolment
•7.Current acute decompensated HF or hospitalization due to decompensated HF <4 weeks prior to enrolment
•8.Hepatic impairment aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment
•9.Severe (eGFR <30 mL/min/1.73 m2 by Schwartz formula), unstable or rapidly progressing renal disease at the time of enrolment.

发起方

Dr Nabeel Faisal V