Dapagliflozin in children with heart failure

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite of <br/ ><br>1.First worsening heart failure; defined by signs and symptoms of worsening heart failure that requires intensification of HF therapy. <br/ ><br>2.First hospitalization for HF <br/ ><br>3.CV death <br/ ><br>Timepoint: 6 months <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
BNPTimepoint: 6 months;Change in NYHA/ROSS HF class from enrolment to 6 months of therapyTimepoint: 6 months;To study the incidence of adverse events <br/ ><br>â?¢Serious adverse events <br/ ><br>â?¢Discontinuation due to adverse event <br/ ><br>â?¢Adverse events of interest <br/ ><br>oVolume depletion, renal events <br/ ><br>oElectrolyte abnormalities <br/ ><br>oMajor hypoglycaemic events <br/ ><br>oDKA <br/ ><br>oArrhythmias <br/ ><br>Timepoint: 6 months