Dapagliflozin in pediatric heart failure with reduced ejection fraction – A randomized pilot study.
Background: Dapagliflozin (DAPA), a sodium-glucose cotransporter-2 inhibitor, has shown promise in adult patients with heart failure (HF), but its safety and efficacy in children remain underexplored. Methods: In this randomized controlled pilot study, 20 children (aged 1–12 years, median 2.2 years,...
| Publicado en: | Annals of Pediatric Cardiology Vol. 18; no. 4; pp. 323 - 331 |
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| Autores principales: | , , , , , , , , , , |
| Formato: | research tables/charts randomized controlled trial Journal Article |
| Publicado: |
Wolters Kluwer India Pvt Ltd
Jul/Aug2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=190609711&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 190609711 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 09742069 589G jtl: Annals of Pediatric Cardiology issn: 09742069 maglogo: N pubinfo: dt: Jul/Aug2025 vid: 18 iid: 4 pid: 16919 pub: Wolters Kluwer India Pvt Ltd artinfo: ui: 190609711 190609711 190609711 10.4103/apc.apc_188_25 190609711 ppf: 323 ppct: 8 formats: tig: atl: Dapagliflozin in pediatric heart failure with reduced ejection fraction – A randomized pilot study. aug: au: Faisal, Nabeel Valappil Arumugam, Praveen Mohankumar, Shivaprasad Pannasamudra Kadiyani, Lamk Handa, Ankur Ramakrishnan, Lakshmy Datta, Sudip Kumar Seth, Sandeep Narang, Rajiv Gupta, Saurabh Kumar Ramakrishnan, Sivasubramanian affil: Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India sug: subj: Dapagliflozin Therapeutic Use Heart Failure Drug Therapy Ventricular Dysfunction, Left Drug Therapy Patient Safety Evaluation Drug Efficacy Evaluation Treatment Outcomes Evaluation Human Male Female Child, Preschool Child Descriptive Statistics Randomized Controlled Trials Random Assignment Pilot Studies Echocardiography Electrocardiography Anthropometry Prospective Studies Unpaired T-Tests Mann-Whitney U Test Chi Square Test Fisher's Exact Test Analysis of Variance Data Analysis Software Child, Preschool: 2-5 years Child: 6-12 years Male Female ab: Background: Dapagliflozin (DAPA), a sodium-glucose cotransporter-2 inhibitor, has shown promise in adult patients with heart failure (HF), but its safety and efficacy in children remain underexplored. Methods: In this randomized controlled pilot study, 20 children (aged 1–12 years, median 2.2 years, and eight boys) with dilated cardiomyopathy and HF with reduced ejection fraction (HFrEF) were randomized to receive either DAPA plus standard therapy (n = 9) or standard therapy alone (n = 11). The primary outcome was a composite of worsening HF, HF hospitalization, and cardiovascular death over a 6-month follow-up period. Secondary outcomes included adverse events, such as changes in renal function, volume status, serum electrolyte levels, blood glucose levels, ketoacidosis, and urinary tract infections. The other secondary efficacy outcomes included N-terminal pro-brain natriuretic peptide (NT-proBNP) levels and changes in functional class from baseline to 6 months. Results: The primary composite outcome occurred in three patients: one (cardiovascular death) in the DAPA group and two (cardiovascular death and HF hospitalization) in the control group (11.1% vs. 18.25%, P = 0.58). Two patients in the DAPA group developed transient prerenal acute kidney injury. Mild hyponatremia was present in 45% of patients during follow-up, with no significant difference between the groups (P = 0.34). No cases of ketoacidosis or urinary infection were observed in DAPA group. Both the groups demonstrated improvements in NT-proBNP levels and functional class, with no statistically significant differences observed. Conclusions: Dapagliflozin was generally well tolerated in children with HFrEF, with a safety profile similar to that of the control group. However, no significant differences were observed in efficacy outcomes between the groups in this pilot study. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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