CTRI/2022/12/048440
Recruiting
未知
Dapagliflozin in pediatric heart failure with reduced ejection fraction (Dapa-Ped HF) - A randomized pilot study - Dapa-Ped HF
Dr Nabeel Faisal V0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: I420- Dilated cardiomyopathy
- Sponsor
- Dr Nabeel Faisal V
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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