GACH Study–Tolerability and efficacy of SGLT2 inhibitors in adults with congenital heart disease and heart failure - 27/08/26
, Clement Karsenty 2, Jean Louchet 3, Reaksmei Ly 4, Nicolas Combes 4, Pascal Amédro 5, Mathieu Albertini 6, Fabien Labombarda 7, Jelena Radojevic 8, Laurianne Le Gloan 9, Alexandre Delarue 10, Claire Massardier 11, Bouzguenda Ivan 12, Marie Agness Bakhoum 13, Anne Claire Casalta 14, Sophie Guillaumont 15, Aurelien Capogna 16, Bruno Lefort 17, Sebastien Hascoet 18, Pamela Moceri 19Résumé |
Introduction |
Heart failure in patients with congenital heart disease increases with age. The effect of SGLT2 inhibitors in this population is poorly studied in literature.
Methods and objective |
To study the tolerability and efficacy of SGLT2 inhibitors in patients with heart failure due to congenital heart disease. The primary endpoint was a composite endpoint combining a significant decrease in NYHA class and/or BNP (or NT-proBNP) at 6–12 months.
Results |
140 patients were included in 14 French centers from December 2023 to May 2025 (including 20 Fontan patients, 37 transposition of the great arteries with atrial switch, and 13 Congenitally Corrected Transposition of the Great Arteries). Mean age was 47 ± 13 years. 61% were male. Mean follow-up duration was 8.7 ± 3.4 months. Mean BMI was 26 ± 5. Thirty-nine (30%) patients were overweight (BMI 25 to 30), and 30 (23%) had moderate or severe obesity (BMI 30 to 40). Eighty-four patients (60%) had a history of arrhythmia (flutter, atrial fibrillation, ventricular tachycardia), 39 (28%) had a pacemaker (including 4 triple chamber), and 31 (22%) had a defibrillator. Regarding cardiovascular risk factors: 6 (4%) patients had diabetes, 13 (9%) hypertension, and 5 (3.6%) chronic kidney disease.
132 patients were treated with dapaglifozine, and 8 patients with empaglifozine. 88 patients (67%) (95% CI [59%; 76%]) met the primary endpoint (78% of systemic right ventricles, 59% of single ventricles). The presence of congestive signs in patients decreased significantly from 24% to 10% at 6–12 months ( P = 0.0015). Median NT-proBNP level at baseline was 1098 ng/L [24; 1249] and decreased to 781 ng/L [210; 1001] at 6–12 months. Echocardiographic ejection fraction of the systemic ventricle increased significantly from 41 ± 12% to 42 ± 12% ( P = 0.049). There was no significant difference in ejection fraction on MRI (but only 38 patients had MRI at inclusion) nor on peak VO 2 .
Five patients (4%) experienced adverse event (3 urogenital infections, 2 fungal infections), leading to temporary discontinuation in 2 patients and permanent discontinuation in 1.
Conclusion |
SGLT2 inhibitors were well tolerated in patients with congenital heart disease and significantly improved NYHA class and/or NT-proBNP levels in 67% of cases, and in 78% of cases in patients with a systemic right ventricle, despite an increased risk of urogenital infections found in 4% of cases.
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Vol 119 - N° 8-9S
P. S244 - août 2026 Retour au numéro
Article précédent
- Sex differences in outcomes after transcatheter pulmonary valve implantation: No impact on endocarditis but increased reintervention risk in males
- Sebastien Hascoet, Aleksander Kempny, Ali Houeijeh, Maria Jesus Del-Cerro-Marin, James R. Bentham, Nicolas Combes, Clement Karsenty, Sophie-Guiti Malekzadeh Milani, Hélène Bouvaist, Zakaria Jalal, Patrice Guérin, Julie Lourtet-Hascoet, Philippe Aldebert, Anja Tengler, Stephane Morisset, Alain Fraisse
- Long-term follow-up of adults with Fontan circulation: Predictors of death or transplantation
- Candice Oger, Ghita Afilal, Gilles Soulat, Pauline David, Caroline Ghanime, Alexis Barat, Antoine Legendre, Anne-Solene Chaussade, Elie Mousseaux, Victor Waldmann, Laurence Iserin, Mathieu Albertini
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